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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 InformationDatabase | Title | Recruitment | Conditions | Intervention | Sponsored By | Gender | |||||
---|---|---|---|---|---|---|---|---|---|---|---|
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. | ||
Clinicaltrials.gov | FB4 (Framingham, Boston, Bloomington, Birmingham, and Baylor) | Terminated | Obesity | Behavioral - Feeding Study | Boston Children's Hospital, Indiana University, University of Alabama at Birmingham, Framingham State University, Baylor University, Other, Other, Other, Other, Other | 18 Years - 50 Years | N/A | Interventional | This study will evaluate the effects of dietary carbohydrate and sugar consumption, independent of energy content, on body fatness and metabolism in a rigorous feeding study. | ||
Clinicaltrials.gov | Risk Assessment of Long-Haul Truck Drivers | Completed | Gonorrhea, Chlamydia Infections, Hepatitis B, Hepatitis C, Diabetes Mellitus, Hypertension, Obesity, HIV Infections, Hyperlipidemia | Wake Forest University Health Sciences, National Institute of Mental Health (NIMH), University of Alabama at Birmingham, Other, NIH, Other | 21 Years - N/A | Observational | International studies have repeatedly documented a substantial prevalence of sexual risk behaviors and high rates of human immunodeficiency virus (HIV) and other sexually transmitted infections (STI) ranging from 5%-56% amongst long-distance truck drivers ("truckers") living in diverse international settings including India, Bangladesh, South Africa, China, Laos and Thailand. The prevalence of sexual risk factors and STI/HIV in US drivers is unknown. This proposal will provide both qualitative and quantitative data on HIV risk behaviors by interviewing and testing truckers working for established long-distance trucking firms, the sector which accounts for most of the jobs in the trucking and warehousing industry in the United States. The data obtained from this study will be used to inform the development of an HIV prevention intervention for long-haul truck drivers. | ||||
Clinicaltrials.gov | Exercise Training in Obesity-prone Black and White Women | Completed | Obesity | Behavioral, Behavioral, Behavioral - Diet, Aerobic exercise, Resistance exercise | University of Alabama at Birmingham, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Other, NIH | Female | 21 Years - 41 Years | N/A | Interventional | Overweight premenopausal Black and White women are randomized to either diet-only, diet+aerobic or diet+resistance exercise training. Diet/behavior intervention, with or without the aerobic or resistance exercise training, will be provided throughout the 18 months of study. Major outcomes will include measures of perceived and physiologic difficulty of exercise (cardiac, ventilatory, electromyographic responses to standardized exercise tasks); aerobic fitness; strength fitness; and spontaneous free-living energy expenditure (all derived from doubly labeled water). The results will provide insight into the effectiveness of, and the mechanisms by which, different types of exercise training can improve physical fitness, spontaneous engagement in physical activities of daily living and, in turn, weight-loss maintenance. | |
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. | ||
Clinicaltrials.gov | Development of an Adaptive Treatment for Weight Loss in People With Prediabetes | Recruiting | PreDiabetes, Obesity | Behavioral, Behavioral - High Carbohydrate Diet, Reduced Carbohydrate Diet | University of Alabama at Birmingham, General Mills, Other, Industry | 18 Years - 75 Years | N/A | Interventional | This 16-week study will use an experimental approach called the Sequential Multiple Assignment Randomized Trial to help determine which combination and sequence of weight loss program features are most effective in people who are at risk for type 2 diabetes. Participants in the study will be initially randomized to consume either a high or reduced carbohydrate diet. After 4 weeks, participants will be identified as Responders (6% weight loss) or Non-Responders (<6% weight loss). Responders will continue with their initial randomized group for the remainder of the trial. Non-responders will be re-randomized to 2nd stage interventions of either including additional exercise counseling and training or beginning a time restricted eating protocol for the remainder of the trial. | ||
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. | ||
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. | ||||
Clinicaltrials.gov | Atrial Natriuretic Peptide and Regulation of Cardiometabolic Health: A Genotype-Guided Human Physiological Study | Not yet recruiting | Cardiovascular Diseases, Natriuretic Peptides, Cardiometabolic Diseases, Energy Expenditure, Glucose Metabolism, Exercise, Obesity | Dietary Supplement, Other, Other, Other - Study diet, Exercise capacity VO2 max determination, Exercise Challenge, Glucose Challenge | University of Alabama at Birmingham, Other | 18 Years - N/A | N/A | Interventional | Natriuretic Peptides (NP) are hormones produced by the heart, and they have a wide range of favorable metabolic benefits. Lower levels of these hormones are associated with an increased likelihood of the development of diabetes and poor cardiometabolic health. Obese and Black individuals have ~30% lower levels of NP and are at a greater risk of developing cardiovascular (CV) events as compared to lean and White counterparts. Some people have common genetic variations that cause them to have ~20% lower NP levels. Similar to other low NP populations, these individuals with low NP genotype (i.e., carrying a common genetic variation called rs5068) are at a greater risk of developing cardiometabolic diseases. By understanding the NP response following the exercise challenge and the glucose challenge in individuals with genetically lower NP levels will help us understand how to improve cardiometabolic health in them. | ||
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. | ||
Clinicaltrials.gov | The Diurnal Rhythm in Natriuretic Peptide Levels | Completed | Natriuretic Peptides, Obesity, Nocturnal Blood Pressure | Other - standardized Study Diet | University of Alabama at Birmingham, Other | Male | 18 Years - 40 Years | N/A | Interventional | The purpose of the study to assess the diurnal rhythm in natriuretic peptide levels and its temporal relationship with nocturnal blood pressure in obese and African-American individuals as compared with lean and white individuals. | |
Clinicaltrials.gov | Ketones Supplementation and Postprandial Lipemia | Withdrawn | Obesity, Overweight and Obesity, Overweight, Triglycerides High | Dietary Supplement, Dietary Supplement - Ketone Ester, Ketone Salt | University of Alabama at Birmingham, Other | Male | 25 Years - 45 Years | N/A | Interventional | This study determines whether different forms of ketones supplemented prior to a meal lower the triglyceride (fat) content in the blood of overweight and obese individuals. Through a randomized crossover design, participants (n=15) will participate in each of the following three experimental groups (no treatment control, ketone ester, ketone salt), with a 5-14 day washout period between each experimental visit. | |
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. | ||
Clinicaltrials.gov | CARE Trial: Comparing Different Levels of Calorie Reduction for Weight Loss | Active, not recruiting | Overweight, Obesity | Behavioral - Energy Reduction | University of Alabama at Birmingham, Other | 21 Years - 75 Years | N/A | Interventional | This research study will compare two weight loss programs that provide different recommendations for how to reduce your energy (or calorie) intake to achieve weight loss in an effort to determine if fixed calorie reduction or varied calorie reduction is more effective for weight loss. | ||
Clinicaltrials.gov | Weight Management Counseling in Medical Schools | Active, not recruiting | Obesity | Behavioral, Behavioral - Multi-Modal Education (MME), Traditional Education (TE) | University of Massachusetts, Worcester, National Cancer Institute (NCI), Brown University, Creighton University, Georgetown University, Harvard School of Public Health (HSPH), Oregon Health and Science University, University of Alabama at Birmingham, University of Iowa, University of Louisville, University of Pennsylvania, Other, NIH, Other, Other, Other, Other, Other, Other, Other, Other, Other | 18 Years - N/A | N/A | Interventional | Eight U.S. medical schools will be participating in the study: Weight Management Counseling in Medical Schools, also known as MSWEIGHT. This is a five-year randomized controlled trial (RCT) designed to compare the efficacy of two approaches to learning weight management counseling: 1)traditional education (TE) and; 2) multi-modal educational intervention (MME). The study aims are to refine and compare the efficacy of MME to TE on observed student weight management counseling skills measured through the primary outcome, the Objective Structured Clinical Examination (OSCE). | ||
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. | ||||
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. | |
Clinicaltrials.gov | Utility of Ultrasound in Identification of Midline and Placement of Epidural in Severely Obese Parturients | Completed | Epidural Anesthesia, Spinal Ultrasound, Obesity | Procedure, Device - Palpation, Ultrasound | University of Alabama at Birmingham, Other | Female | 19 Years - 45 Years | N/A | Interventional | This study will address the utility of ultrasound in the placement of an epidural catheter in severely obese parturients. Identification of midline can often be difficult using the standard method of palpation in obese patients. The Investigator will determine if the use of ultrasound decreases the amount of time and number of attempts required to place the epidural. | |
Clinicaltrials.gov | Simulated-altitude to Optimize Aerobic Exercise Among Breast Cancer Survivors With Limited Mobility | Completed | Obesity, Breast Cancer | Other, Behavioral - Walking+simulated-altitude, Walking (control) | University of Alabama at Birmingham, Other | Female | 18 Years - 70 Years | N/A | Interventional | The study will evaluate the utility of hypoxic exercise training to improve cardiovascular and metabolic health among obese breast cancer survivors. While participants exercise, a lower fraction of inspired oxygen will be used to simulate a higher altitude. This approach removes the mechanical strain needed to sustain moderate-to-vigorous exercise intensity which is believed to support exercise tolerance. Participants are randomized to either the treatment (walking+simulated-altitude) or control (walking under normoxic conditions). |
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