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Integrated Clinical Trials is a virtual database currently indexing clinical trials from: EU Clinical Trials Register and ClinicalTrials.gov.
(last updated: Nov 28, 2022)
Clinical Trials Information| Database | Title | Recruitment | Conditions | Intervention | Sponsored By | Gender | |||||
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Clinicaltrials.gov | Energy Expenditure & Activity During & After Exercise-Induced Weight Loss | Completed | Obesity | Behavioral - Walking exercise | University of Colorado, Denver, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Other, NIH | 18 Years - 55 Years | N/A | Interventional | This project is aimed at determining whether an exercise-based weight loss intervention causes a compensation in some component of energy expenditure such that the increase in measured energy expenditure is less than the added exercise. The study will compare two separate exercise interventions to determine if this is influenced by exercise intensity. | ||
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Clinicaltrials.gov | Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents | Not yet recruiting | Type 2 Diabetes, Depression, Insulin Resistance, Obesity, Adolescent Development | Behavioral, Behavioral, Behavioral - Mindfulness-Based Intervention, Cognitive-Behavioral Therapy, Health Education | Colorado State University, National Center for Complementary and Integrative Health (NCCIH), University of Colorado, Denver, Children's National Health System, Uniformed Services University of the Health Sciences, Other, NIH, Other, Other, U.S. Fed | 12 Years - 17 Years | N/A | Interventional | Rates of type 2 diabetes (T2D) in adolescents have escalated. Adolescent-onset is associated with greater health comorbidities and shorter life expectancy than adult-onset T2D. T2D is preventable by decreasing insulin resistance, a physiological precursor to T2D. T2D prevention standard-of-care is lifestyle intervention to decrease insulin resistance through weight loss; yet, this approach is insufficiently effective in adolescents. Adolescents at risk for T2D frequently experience depression, which predicts worsening insulin resistance and T2D onset, even after accounting for obesity. Mindfulness-based intervention (MBI) may offer a targeted, integrative health approach to decrease depression, and thereby, ameliorate insulin resistance in adolescents at risk for T2D. In a single-site, pilot randomized controlled trial (RCT), we established initial feasibility/acceptability of a 6-week group MBI program, Learning to BREATHE, in adolescents at risk for T2D. We demonstrated feasible single-site recruitment, randomization, retention, protocol adherence, and MBI acceptability/credibility in the target population. Our preliminary data also suggest MBI may lead to greater reductions in stress-related behavior, vs. CBT and a didactic/health education (HealthEd) control group. The current study is multisite, pilot RCT to test multisite fidelity, feasibility, and acceptability in preparation for a future multisite efficacy trial that will have strong external validity, timely recruitment, and long-term follow-up. Adolescents (N=120) at risk for T2D will be randomized to MBI vs. CBT vs. HealthEd and followed for 1-year. Specific aims are to: (1) test multisite fidelity of training and implementation of 6-week group MBI, CBT, and HealthEd, to teens at risk for T2D; (2) evaluate multisite feasibility/acceptability of recruitment, retention, and adherence for an RCT of 6-week group MBI, CBT, HealthEd with 6-week and 1-year follow-up; and (3) modify intervention training/implementation and protocol procedures in preparation for a future, fully-powered multisite efficacy RCT. | ||
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Clinicaltrials.gov | PATHWEIGH: Pragmatic Weight Management in Primary Care | Enrolling by invitation | Obesity | Other, Other - Weight management care path, Control | University of Colorado, Denver, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Other, NIH | 18 Years - 89 Years | N/A | Interventional | The study examines patient weight loss and maintenance, associated predictors (patient health characteristics and demographics), and contextual factors in the practice environment that influence the intervention's adoption, implementation, and sustainability. This will be achieved through a mixed methods implementation study including collection and analysis of de-identified clinical data, surveys, observations, and interviews. | ||
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Clinicaltrials.gov | Exploring the Anti-inflammatory Properties of Cannabis and Their Relevance to Insulin Sensitivity | Recruiting | Type 2 Diabetes, Obesity, Cannabis Use, Insulin Sensitivity | University of Colorado, Boulder, University of Colorado, Denver, Other, Other | 21 Years - 40 Years | Observational | This study tests the effects of cannabinoid levels in blood on inflammation and insulin sensitivity both acutely and chronically in individuals across the weight spectrum. To that end, the study employs two observational designs: 1) A study of acute effects with intermittent cannabis users and 2) A study in which current cannabis users will select one of three cannabis strains for four weeks and are compared to a matched control group who do not use cannabis to study chronic effects. Blood levels of THC and CBD, inflammatory biomarkers, and insulin resistance will be measured in both studies. | ||||
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Clinicaltrials.gov | Time Restricted Feeding and Metabolic Rhythms | Recruiting | Obesity, Diabetes | Behavioral - Time Restricted Feeding | University of Colorado, Denver, Other | 20 Years - 50 Years | N/A | Interventional | Current guidelines for the prevention and treatment of obesity focus on caloric restriction diets and increasing physical activity, but long-term compliance to these strategies is poor. The timing of meal intake relative to the light-dark and sleep-wake cycle is rarely considered in metabolic health; and modifying meal timing is likely easier to implement in daily life than reducing caloric intake and/or increasing physical activity. This project will test whether restricting the timing of energy intake to a short-defined period during wakefulness can be used to improve fuel utilization patterns and enhance circadian rhythms in metabolic tissues to optimize health. | ||
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Clinicaltrials.gov | Renal HEIR Study: Renal Hemodynamics, Energetics and Insulin Resistance in Youth Onset Type 2 Diabetes Study | Recruiting | Type 2 Diabetes Mellitus, Obesity, Nephropathy, Adolescent Obesity | Drug, Drug, Procedure - Aminohippurate Sodium Inj 20%, Iohexol Inj 300 MG/ML, Renal Biopsy | University of Colorado, Denver, Other | 12 Years - 21 Years | Phase 1/Phase 2 | Interventional | Type 2 diabetes (T2D) in youth is increasing in prevalence in parallel with the obesity epidemic. In the US, almost half of patients with renal failure have DKD, and ≥80% have T2D. Compared to adult-onset T2D, youth with T2D have a more aggressive phenotype with greater insulin resistance (IR), more rapid β-cell decline and higher prevalence of diabetic kidney disease (DKD), arguing for separate and dedicated studies in youth-onset T2D. Hyperfiltration is common in youth with T2D, and predicts progressive DKD. Hyperfiltration may also be associated with early changes in intrarenal hemodynamic function, including increased renal plasma flow (RPF) and glomerular pressure. Despite the high prevalence and gravity of DKD in youth-onset T2D, widely effective therapeutic options are lacking. The investigators' preliminary data support a strong association between IR and hyperfiltration in youth-onset T2D, but the pathology contributing to this relationship remains unclear. A better understanding of the pathophysiology underlying hyperfiltration and its relationship with IR is critical to inform development of new therapeutics. The investigators' overarching hypotheses are that: 1) hyperfiltration in youth-onset T2D is associated with changes in intrarenal hemodynamics, resulting in increased renal oxygen demand, 2) the demand is unmet by the inefficient fuel profile associated with IR (decreased glucose oxidation and increase free fatty acid [FFA] oxidation), resulting in renal hypoxia and ultimately renal damage. To address these hypotheses, the investigators will measure peripheral insulin sensitivity, adipose insulin sensitivity (FFA suppression), glomerular filtration rate (GFR), RPF, and renal oxygenation in youth with T2D (n=60), obesity (n=20) and in lean (n=20) controls. To further investigate the mechanisms of renal damage in youth with T2D, two optional procedures are included in the study: 1) kidney biopsy procedure and 2) induction of induced pluripotent stem cells (iPSCs) to assess morphometrics and genetic expression of renal tissue. | ||
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Clinicaltrials.gov | Appetite Regulation in Older-Aged Obese Individuals | Completed | Obesity, Aging | Dietary Supplement, Procedure, Procedure - 3-day diet Run-in, fMRI, Intravenous catheter placed for blood draws | University of Colorado, Denver, Other | 21 Years - 85 Years | N/A | Interventional | This study plans to learn more about how age and weight impact appetite and food intake. Specifically, this study is being done to see whether age and obesity impact appetite and the brain's response to food. In this study the investigators will be evaluating how participants brains respond to food images as well as your food-related behaviors and hormones. The investigators will be comparing older individuals aged 65 to 85 years who are normal weight compared to those who are obese. The Investigators will then compare older aged individuals to younger adults aged 21 to 45 years. | ||
Clinicaltrials.gov | Sleep Timing and Insulin Resistance in Adolescents With Obesity | Completed | Obesity | University of Colorado, Denver, Other | 15 Years - 19 Years | Observational | This study examines the relationship between sleep timing and insulin resistance in adolescents with obesity. The investigators also aim to develop a physiologically-based mathematical model of adolescent sleep/wake and circadian interactions. | ||||
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Clinicaltrials.gov | Helping Moms to be Healthy After Baby | Completed | Weight Loss, Diet Modification, Obesity | Behavioral, Behavioral - Observation Group participants, Lifestyle group participants | University of Colorado, Denver, Colorado Clinical & Translational Sciences Institute, National Center for Advancing Translational Science (NCATS), Other, Other, NIH | Female | 18 Years - 50 Years | N/A | Interventional | Low-income and minority women are at increased risk for postpartum weight retention (i.e. retaining weight after pregnancy) and consequent persistent obesity. Women who are obese pre-pregnancy are 3-5 times more likely to gain weight, rather than lose weight, in the postpartum period than non-obese women. Aims for this pilot study are listed below: Aim 1: To evaluate the feasibility and acceptability of a multi-component novel weight loss intervention delivered in a WIC setting to a population of low-income, predominantly racial/ethnic minority, obese, postpartum women. Aim 2: To evaluate differences in weight change, diet, physical activity, self-efficacy, readiness to change, motivations to eat between intervention and control participants to determine preliminary intervention efficacy over a 12-week period. | |
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Clinicaltrials.gov | Community Outreach - Obesity Prevention Trial (CO-OPT) | Active, not recruiting | Obesity, Overweight, Children | Behavioral - Patient navigation | Denver Health and Hospital Authority, University of Colorado, Denver, Other, Other | 2 Years - 6 Years | N/A | Interventional | The purpose of this research is to investigate the effectiveness of a community health worker-based program as an adjunct to clinical services regarding childhood obesity management. This family-centered program will be delivered in the community and homes of enrolled families. The primary outcome will compare change in age-gender specific body-mass-index (BMI) z-score (zBMI) over time. All Denver Health children and families will be enrolled at study inception and receive the intervention in 1 of 5 defined 6-month stepped wedge engagements. The intervention lasts for 6 months and the time prior to engagement in the intervention will serve as the control period. Intervention construct validity will be evaluated using data on diet, activity, and fitness. The primary goal is to examine the effect of the intervention in reducing the zBMI in the index patient and secondarily on any participating family members. We will test effectiveness among demographic groups under-represented in prior studies, including very young children and Latinos. Results from this study will inform future intervention modifications and permit effect size estimation and power calculations for future randomized trials that include a community health worker-based obesity prevention and treatment program. During the course of the study, an obesity registry will be designed and implemented within an integrated safety-net healthcare system to measure primary obesity outcomes in a low-income population and conduct analyses. The community health worker will be using several new technologies (e.g., text messaging and patient relationship manager [PRM]) as an adjunct when working with an obese child and his/her family. Targeted training for clients, providers and CHW will be part of the prevention strategies implemented during the grant period, these will include motivational interviewing. All of these (i.e., obesity registry, technologies and training) will have an evaluative component. | ||
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Clinicaltrials.gov | Optimal Timing of Exercise Initiation Within a Lifestyle Weight Loss Program | Completed | Obesity | Behavioral, Behavioral - Sequential BT, Standard BT | University of Colorado, Denver, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Other, NIH | 18 Years - 55 Years | N/A | Interventional | The primary aim of this study is to evaluate the extent to which an exercise intervention timed after diet-induced weight loss (rather than initiated at the same time) improves exercise adherence and long-term weight loss. An 18 month randomized trial will be used to compare two behavioral weight loss programs; standard behavioral therapy (Standard BT) and sequential behavioral therapy (Sequential BT). The Standard BT group will receive a traditional behavioral weight loss program where diet and exercise changes are initiated at the same time. The Sequential BT group will receive a program that focuses solely on dietary changes in the initial 6 months, and then incorporates exercise in the ensuing 6 months. Both groups will be followed for 18 months to assess long-term weight loss. The hypothesis is that delivery of diet and exercise interventions in sequence will result in improved adherence to exercise and weight loss at 18 months when compared to a traditional program in which identical diet and exercise interventions are initiated at the same time. This study could identify a strategy that could aid in the development of more effective obesity treatment programs and help more people achieve and sustain a weight loss. | ||
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Clinicaltrials.gov | Effects of Estrogen Deficiency on Energy Expenditure | Completed | Obesity | Drug - Estrogen suppression | University of Colorado, Denver, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Other, NIH | Female | 20 Years - 40 Years | N/A | Interventional | Menopause is associated with weight gain, but the reasons why are not clear. In this study, the investigators will determine if reducing estrogen levels causes a decrease in the ability of the body to produce heat. If so, this would suggest this is one way that menopause may cause weight gain. | |
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Clinicaltrials.gov | Females, Aging, Metabolism, and Exercise | Completed | Obesity | Drug, Behavioral, Drug - GnRH agonist, Supervised cardiovascular exercise, Placebo | University of Colorado, Denver, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Other, NIH | Female | 40 Years - 60 Years | N/A | Interventional | This study is designed to determine whether a reduction in hormones (such as occurs during menopause) causes a decrease in calories burned during physical activity. This study will also determine whether a reduction in hormones decreases calories burned while sleeping, resting, and eating and whether an exercise intervention can prevent this. | |
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Clinicaltrials.gov | Parent Perceptions of Weight Status: Impact of a Pilot Intervention | Completed | Obesity | Behavioral - Education Intervention | University of Colorado, Denver, Other | 3 Years - 13 Years | N/A | Interventional | This pilot study is a randomized controlled trial with an embedded cross sectional study exploring parental perceptions of their weight status and how it affects their perceptions of their child's weight status. This study uses an educational intervention in which parents are informed of their actual weight status and how it affects their child's health. We will study the effect of this intervention on the parent's perceptions of and level of concern for their own and their child's weight status. | ||
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Clinicaltrials.gov | Prevention of Obesity in Women Via Estradiol Regulation | Completed | Obesity | Drug, Drug, Behavioral - leuprolide acetate, Estradiol Transdermal, progressive resistance exercise training | University of Colorado, Denver, National Institute on Aging (NIA), Other, NIH | Female | 18 Years - 49 Years | Phase 3 | Interventional | The purpose of this study is to evaluate potential mechanisms by which estradiol deficiency accelerates fat gain and abdominal fat accumulation in women. | |
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Clinicaltrials.gov | Evaluating a Web-Based Cardiovascular Disease Risk Factor Reduction Program Among American Indians | Completed | Cardiovascular Diseases, Diabetes Mellitus, Type 2, Hypertension, Obesity, Tobacco Use Cessation | Behavioral - Chronic disease management Web-based software | Black Hills Center for American Indian Health, University of Washington, University of Colorado, Denver, NuMedics, Inc., Cheyenne River Sioux Tribe Telephone Authority, Missouri Breaks Industries Research, Inc., Cheyenne River Sioux Tribe, Other, Other, Other, Industry, Other, Other, Other | 18 Years - 75 Years | N/A | Interventional | Cardiovascular disease (CVD) is a serious health concern for American Indians, but there have been few behaviorally based programs to lessen CVD risk among this population. The purpose of this study is to evaluate whether a Web-based program, in addition to usual medical care, can lower CVD risk factors among American Indians who have type 2 diabetes and a high risk of developing CVD. | ||
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Clinicaltrials.gov | Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Adolescent Bariatrics: Assessing Health Benefits and Risk | Enrolling by invitation | Obesity | University of Colorado, Denver, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Children's Hospital Medical Center, Cincinnati, University of Pittsburgh Medical Center, University of Alabama at Birmingham, Nationwide Children's Hospital, Baylor College of Medicine, University of Washington, Sanford Health, Other, NIH, Other, Other, Other, Other, Other, Other, Other | 12 Years - 19 Years | Observational | The five Teen-LABS clinical centers use standardized techniques to assess the short and longer-term safety and efficacy of bariatric surgery in adolescents compared to adults. | ||||
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Clinicaltrials.gov | Estrogen Sensitivity and Ovulatory Dysfunction in Obesity | Completed | Obesity, Infertility | Drug, Drug, Drug - Estradiol, Gonadotropin-releasing hormone (GnRH), Progesterone | University of Colorado, Denver, Other | Female | 18 Years - 42 Years | N/A | Interventional | The sole purpose of this study is to evaluate pathophysiology of disease. The disease state that is being evaluated is the obesity-related alterations in reproductive hormones - The obesity epidemic in the United States is advancing at an accelerated pace. It is estimated that by 2015, 41% of U.S. adults will be obese as defined by a body mass index (BMI) of greater than 30 kg/m2. The U.S. government's 2010 Dietary Guidelines regard obesity as the single greatest health hazard in this century. Female adult obesity is associated with menstrual cycle irregularities, ovulatory dysfunction and a higher risk of obstetrical complications. This reproductive phenotype of obesity is worsened by further increases in BMI and is not solely due to anovulatory infertility. While the association of adiposity with subfertility is well documented in population studies, the underlying mechanisms remain poorly understood. The main objective of this proposal is to clarify the nature of the obesity-related reproductive endocrine abnormalities and identify potential etiologies amenable to therapy. - Hypothesis: The hypothalamic-pituitary axis is abnormally sensitive to estradiol negative feedback in obesity. | |
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Clinicaltrials.gov | Skeletal Muscle Diacylglycerol and Sphingolipids - Impact of Localization and Species on Insulin Resistance in Humans | Active, not recruiting | Diabetes Mellitus, Type 2, Pre-diabetes, Obesity | Behavioral - Lifestyle | University of Colorado, Denver, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Other, NIH | 30 Years - 50 Years | N/A | Interventional | The rationale for the proposed research is that elucidating changes in localized diacylglycerol (DAG) and sphingolipid species that predict insulin sensitivity will reveal specific localized lipids to target in therapeutics for type 2 diabetes. To attain the overall objective, the investigators propose three specific aims: 1. Identify the influence of sarcolemmal DAG and sphingolipids on cell signaling and insulin sensitivity before and after insulin sensitizing lifestyle interventions. Strong preliminary data shape the hypothesis that sarcolemmal 1,2-disaturated DAG and C18:0 ceramide species will decrease after insulin sensitizing lifestyle interventions, leading to less Protein kinase C (PKC) and Protein phosphatase 2A (PP2A) activation, and enhanced insulin signaling. Skeletal muscle DAG and sphingolipid isomers, species, localization, and de novo synthesis will be measured before and after diet-induced weight loss or exercise training interventions in obese men and women. Insulin sensitivity will be measured using insulin clamps, and muscle lipids using Liquid Chromatography Mass Spectrometry (LC/MS). 2. Determine the impact of mitochondrial/ER (endoplasmic reticulum) DAG and sphingolipids on mitochondrial function and ER stress in vivo, before and after insulin sensitizing lifestyle interventions. The investigators hypothesize, again based on preliminary data, that mitochondrial/ER sphingolipids will decrease, yet DAG will increase after insulin sensitizing lifestyle interventions, and each will associate with increased insulin sensitivity. Changes in sphingolipids will relate to increased mitochondrial function, less ER stress, reactive oxygen species (ROS), and acyl-carnitine formation, while changes in DAG will relate to increased mitochondrial content and dynamics. 3. Identify the effect of exogenous DAG and sphingolipids on mitochondrial function in vitro, before and after insulin sensitizing lifestyle interventions. The working hypothesis is that DAG and sphingolipids will reduce mitochondrial respiration and increase ROS and acyl-carnitine content, but will be attenuated after endurance exercise training. The proposed research is innovative because it represents a substantive departure from the status quo by addressing cellular compartmentalization of bioactive lipids. The investigators contribution will be significant by identifying key species and locations of DAG and sphingolipids promoting insulin resistance, as well as mechanisms explaining accumulation that could be modified by insulin sensitizing therapeutic interventions. | ||
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Clinicaltrials.gov | How Gas-Filled Intragastric Balloons or Endoscopic Sleeve Gastroplasty Affect Hunger, Hunger Hormones, and Gastric Emptying Compared to Meal Replacements | Recruiting | Obesity | Device, Dietary Supplement, Procedure - GF-IGB: Obalon Balloon, Medically Supervised Meal Replacement Program: My New Weigh, Endoscopic sleeve gastroplasty: (ESG) | University of Colorado, Denver, Other | 22 Years - 65 Years | N/A | Interventional | The disease obesity continues to be a major health issue in the US with over one third of the population having a mass index >30 kg/m2. Obesity is associated with serious cardiometabolic complications including diabetes, hypertension, dyslipidemia and myocardial infarction. Rates of successful obesity treatment with weight loss and weight maintenance remain low. Several endoscopic bariatric therapies and procedures have been approved for use in the United States, including three intragastric balloon systems (2 fluid-filled and one gas-filled) and endoscopic sleeve gastroplasty (ESG), both of which have lower risks than bariatric surgery and do not alter gastrointestinal anatomy. Weight loss with all intragastric balloons and ESG is higher than lifestyle therapy or weight loss medications, but less than bariatric surgery. Unlike weight loss medications where weight loss from the medication is regained within 6-8 months after therapy ends, weight loss maintenance with intragastric balloons remains high with 66-88.5% of the weight loss maintained 6 months after device removal. Data suggests that space occupying devices with a volume of 400 ml or more in the stomach increase feelings of fullness and result in weight loss, but this does not explain the prolonged effect of weight loss maintenance after balloon removal. Although few studies have investigated the mechanism of action of fluid-filled balloons and one study with 4 patients undergoing ESG on weight loss, these data suggest that gastric emptying as well as space occupation contribute to weight loss. However, no studies have investigated the mechanisms of action of gas filled intragastric balloons on weight loss. Understanding the mechanisms responsible for weight loss with the gas filled intragastric balloon system and ESG as well as any weight loss independent effects on blood glucose control would lay the groundwork for studies evaluating predictors of response to improve patient selection as well as studies understanding the mechanisms behind weight loss maintenance and developing strategies to prolong weight loss maintenance. Therefore, the purpose of this pilot study is to determine the effects 10% total body weight loss (%TBWL) in patients with obesity treated with the intragastric balloon (GF- IGB) system or ESG compared to patients with obesity treated with a meal replacement program (MRP) on 1) gastric emptying, 2) hormonal adaptation to weight loss and 3) hunger. |
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