Surgical or Medical Treatment for Pediatric Type 2 DiabetesSurgical or Medical Treatment for Pediatric Type 2 Diabetes (STOMP-T2D) is a prospective, open-label, controlled clinical trial funded by the National Institutes of Health for a period of 5 years. We propose to study 90 participants who are 13-19 years of age and have type 2 diabetes (T2D) at two sites Cincinnati Children’s Hospital & Children’s Hospital Colorado. We will compare glycemic control, co-morbidities and physiologic responses after vertical sleeve gastrectomy (VSG) vs. advanced medical therapy (AMT) at 1 and 2 years. STOMP-T2D will clarify whether VSG is more effective than AMT in promoting durable glycemic control, improved pancreatic β-cell function, and reduced co-morbidities in youth with T2D. To compare glycemic control, co-morbidities and physiologic responses after vertical sleeve gastrectomy (VSG) vs. advanced medical therapy (AMT) at 1 and 2 years. STOMP-T2D will clarify whether VSG is more effective than AMT in promoting durable glycemic control, improved pancreatic β-cell function, and reduced co-morbidities in youth with T2D. Protocol #: 19-1978 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
PHASE 1, OPEN-LABEL SAFETY STUDY OF UMBILICAL CORD LINING MESENCHYMAL STEM CELLS (CORLICYTE?) TO HEAL CHRONIC DIABETIC FOOT ULCERSProtocol #: 19-1113 Location: University of Colorado Hospital |
Treating PCOS with Exenatide vs Active Lifestyle Intervention (TEAL Study)The study consists of an initial study visit to determine eligibility, 2 inpatient visits (one prior to starting treatment and one at the end of the 4 month treatment intervention), and one short visit midway between the study. Protocol #: 19-0636 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
EnVision CF Multicenter Study of Glucose Tolerance in Cystic FibrosisThe purpose of this study is to find out what the normal levels of insulin and blood sugar are in children and adults with Cystic Fibrosis. In this study participants will undergo a 3 hour Oral Glucose Tolderance Test, OGTT, and have the option to wear a Continuous Glucose Monitor, CGM, and get a DXA scan. Protocol #: 19-0422 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
Long term comparative effectiveness of once weekly semaglutide versus standard of care in a real world adult US population with type 2 diabetes - a randomized pragmatic clinical trialProtocol #: 19-0120 Location: University of Colorado Hospital |
A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic GastroparesisProtocol #: 18-2435 Location: University of Colorado Hospital |
Novel Evaluations of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Women Compared to Age- and BMI-Matched Cisgender AdultsProtocol #: 18-2258 Locations: Rocky Mountain Regional VA Medical Center; University of Colorado Hospital |
A double-blind, randomised, placebo-controlled, parallel group trial to evaluate the efficacy and safety of empagliflozin and linagliptin over 26 weeks, with a double-blind active treatment safety extension period up to 52 weeks, in children and adolescents with type 2 diabetes mellitus.Protocol #: 18-1223 Location: Childrens Hospital Colorado |
Metabolic and Renal Effects of Automated Insulin Delivery Systems in Youth with Type 1 Diabetes MellitusProtocol #: 18-1558 Location: Childrens Hospital Colorado |
A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCYProtocol #: 18-2230 Location: Childrens Hospital Colorado |
The Effect of Exercise on Sleep Quality and Nocturnal Fat Oxidation in Individuals with Metabolic SyndromeProtocol #: 18-0369 Location: University of Colorado Hospital |
A Two-Period, Open-label Trial Evaluating the Efficacy and Safety of Dasiglucagon for the Treatment of Children with Congenital HyperinsulinismProtocol #: 18-2130 Location: Childrens Hospital Colorado |
A Phase 3, Multicenter, Open-Label, Two-Part Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Leuprolide Acetate 45 mg 6-Month Depot Formulation in Children with Central Precocious Puberty (CPP)Protocol #: 18-1716 Location: Childrens Hospital Colorado |
A Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of ISIS 766720 (IONIS GHR-LRX, an Antisense Inhibitor of the Growth Hormone Receptor) Administered Once Every 28 Days for 16 Weeks in Patients with Acromegaly Being Treated with Long-acting Somatostatin ReceptorProtocol #: 18-0756 Location: University of Colorado Hospital |
Oral Amino Acid Nutrition to Improve Glucose Excursions in PCOSProtocol #: 18-0803 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
Intermuscular adipose tissue (IMAT) - protagonist in sarcopenia and insulin resistance in humansProtocol #: 18-0582 Location: University of Colorado Hospital |
A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (!Y10 to <18 years) with Type 2 Diabetes MellitusProtocol #: 17-1809 Location: Childrens Hospital Colorado |
A Phase 2, Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adult Subjects with Congenital Adrenal Hyperplasia V: 2Feb2018Protocol #: 17-1543 Location: Childrens Hospital Colorado |
A PHASE 2, RANDOMIZED, PLACEBO CONTROLLED STUDY OF SAFETY AND EFFICACY FOLLOWING REPEAT-DOSE ADMINISTRATION OF EVINACUMAB (ANTI ANGPTL3) IN PATIENTS WITH SEVERE HYPERTRIGLYCERIDEMIA (SHTG) AT RISK FOR ACUTE PANCREATITIS (R1500-HTG-1522)Protocol #: 17-2118 Location: University of Colorado Hospital |
A Phase 2, Multicenter, Randomized, Single-Blind, Placebo-Controlled Cross-over Study to Assess the Efficacy and Safety of Exendin 9-39 in Patients with Postbariatric HypoglycemiaProtocol #: 17-0366 Location: University of Colorado Hospital |
TESTO: Testosterone Effects on Short Term Outcomes in Infants with XXY V:10/5/2017Protocol #: 17-1317 Locations: Childrens Hospital Colorado; Department Specific Free Standing Clinic |
Copeptin and Nonalcoholic Fatty Liver DiseaseSee above Protocol #: 17-1160 Locations: Anschutz Health and Wellness; UCD Anschutz Health & Wellness Center; University of Colorado Hospital |
A Phase 3, Randomized, Double--Blind, Placebo--Controlled, Multicenter Study to Evaluate Efficacy and Safety of Octreotide Capsules in Patients Who Previously Tolerated and Demonstrated Biochemical Control on Injectable Somatostatin Receptor Ligands (SRL) TreatmentProtocol #: 17-0399 Location: University of Colorado Hospital |
A Phase IA/IB Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of RO7198457 as a Single Agent and in Combination with Atezolizumab in Patients with Locally Advanced or Metastatic TumorsProtocol #: 17-0991 Location: University of Colorado Hospital |
A Phase III, multi-center, randomized, double-blind, 48 week study with an initial 12 week placebo-controlled period to evaluate the safety and efficacy of osilodrostat in patients with Cushing's diseaseThis study is a clinical research study consisting of 2 different periods (in the Core phase) with a total expected duration of 48 weeks and the first 12 weeks being a double-blind placebo controlled portion and then 36 weeks of study drug treament, followed by an optional extension phase for an additional 52 weeks (in which case the total duration of study participation will be up to 100 weeks). It is sponsored by the pharmaceutical company named Novartis (the ?Sponsor?). Around 69 patients will join this study in approximately 35 centers located in different countries (around 12) across the world. The purpose of this study is to confirm the effectiveness and safety of osilodrostat in treating patients with Cushing's Disease. Protocol #: 17-0483 Location: University of Colorado Hospital |
Tissue-specific effects of insufficient sleepThe proposed project is a within-subject consecutive design examining 14 healthy individuals after baseline and after 4 nights of insufficient sleep. Following 7 days of at-home habitual sleep of 9 hours/night and a 3-day lead-in energy balanced diet, participants will be admitted for a 6-night inpatient stay at the UC Denver. Sleep schedules will be verified via sleep logs, time-stamped voice-recorder of bed and wake times, and wrist actigraphy recordings. On the morning after the 1st night in the lab, subjects will undergo including saliva sampling, endothelial function testing, muscle biopsy, fat biopsy, hyperinsulinemic euglycemic clamp. Protocol #: 17-0533 Locations: CTRC-UC Boulder; University of Colorado Hospital |
Cardiovascular Mechanisms of Exercise Intolerance in Diabetes and the Role of SexThis study will define the relationship of cardiac, vascular function and skeletal muscle blood flow (individually and together) to cardiovascular exercise capacity in in men and women with and without type 2 diabetes (T2DM). Identification of differences in the effects of exercise training on the integrated cardiovascular system and metabolism in men and women with and without T2DM will reveal specific adaptive responses to exercise. This study will evaluate & compare exercise function in a total of 60 subjects from the Denver area (30 people with T2DM and 30 overweight control subjects). Protocol #: 17-0356 Location: University of Colorado Hospital |
Comparison of Weight Loss Induced by Intermittent Fasting Versus Daily Caloric Restriction in Individuals with Obesity: A 1-Year Randomized TrialThis study plans to learn more about the best eating patterns for weight loss. Specifically, this study is being done to try to determine if intermittent fasting is as effective for weight loss as daily calorie restriction. In this study, we will be evaluating how your body weight, body composition, laboratory values, energy expenditure, and eating and exercise behaviors change during a 12-month weight loss program. We will also evaluate how your biology, life experiences, thought processes, behaviors, and environment predict how much weight you lose and how well you follow the diet and exercise recommendations in the study. Protocol #: 17-0369 Locations: Anschutz Health and Wellness; UCD Anschutz Health & Wellness Center; University of Colorado Hospital |
GRADE: The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study.Protocol #: 13-0131 Locations: CTRC-adult; University of Colorado Hospital |