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Novel Evaluations of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Women Compared to Age Group-Matched Cisgender Adults
Do you qualify? • Transgender women (i.e., assigned male at birth but identify as female) taking estradiol and spironolactone o Ages 18 to 40 or 50 to 75 years o In good general health o Have been on hormones for at least 1 year o No history of gonadectomy o... Protocol #: 18-2258 |
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Novel Evaluations of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Men Compared to Age Group-Matched Transgender Women and Cisgender Adults
Transgender men (i.e., assigned female at birth but identify as male) taking testosterone o Ages 18 to 40 or 50 to 75 years o In good general health o Have been on hormones for at least 1 year o No history of gonadectomy o No history of cancer, diabetes or heart d... Protocol #: 19-2323 |
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The TULIP Study - Tissue-specific mechanisms UnderLying the unique Insulin resistance Phenotype in T1D
You might be eligible if you: • Are between 20 and 45 years of age and are not obese (body mass index <30 kg/m2) • Do not have a history of cardiovascular disease (heart attack, stroke, coronary bypass surgery or angioplasty) • Are not taking statins for high cholesterol •... Protocol #: 19-0856 |
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Evaluation of Intestinal Permeability and Chronic Inflammation in Patients with Type 2 Diabetes and Obesity Compared to Healthy Lean Controls (IDOS)
Participants will complete 2-3 visits- a screening visit and a testing visit. Some participants will be asked to split screening into 2 visits. All visits include blood draws and the testing visit includes blood draws and frequent urine samples. Participants will also be asked to provide a... Protocol #: 20-2179 |
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Does When You Exercise Matter? A Randomized Trial Comparing the Effect of Morning versus Evening Aerobic Exercise on Weight Loss and Compensatory Behaviors
If you join the study, you will undergo screening evaluations to see if you are eligible to be in the study. If you are eligible to be in the study, you will be randomized to one of two study groups. Which group you are assigned to will be chosen by chance by a procedure similar to the t... Protocol #: 21-3094 |
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REACH - Role of microvascular insulin resistance and cardiorespiratory fitness in diabetes
Participants will undergo baseline testing of heart and blood vessel function as well as skeletal muscle function and exercise ability. Participants will then do cardiovascular exercise for 15 weeks, and all testing will be repeated.... Protocol #: 20-2723 |
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Prolonged Sedentary Behavior in Older Women with and without Type 2 Diabetes: Knowledge, Engagement, and Relationship to Cardiometabolic Risk
Are you interested in participating in a research study to understand the health effects of the time we spend sitting? The ACTIVE Research Lab is looking for: • Women • 60 to 75 years of age • Non-smoker • If Type 2 Diabetes, not being treated with insulin • BMI 25-40 kg/m2 (check ... Protocol #: 19-2758 |
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NightWare Therapeutic Platform for improving Cardiovascular Health in Adults With Nightmares Associated with PTSD
We are recruiting individuals who experience PTSD-associated nightmares to participate in a research study to help us understand if improving sleep quality, by reducing the impact of nightmares can improve cardiovascular health.... Protocol #: 21-5027 |
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A Randomized Parallel Comparison of Semaglutide versus Placebo on Intestinal Barrier (SIB)
Participants will complete 7-8 visits. Some participants will be asked to split screening into 2 visits. After screening, participants will be given either semaglutide or a placebo and will be asked to self-administer the medication once weekly. Four visits will include blood draws and thr... Protocol #: 21-2774 Location: CU Anschutz non-hospital research facilities |
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BURST2D Study: Breaking up sedentary time to improve glucose control in a population at risk for developing type 2 diabetes
The purpose of the study is to compare two different physical activity interventions (BREAK or ONE) to learn about their effects on blood sugar and metabolism. Participants will be randomized to one of two interventions: ONE (45-minutes of brisk walking at least 5 days per week) and BREAK ... Protocol #: 20-1900 |
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PRenatal and Obstetric Maternal Exposures and ISlet Autoantibodies in Early Life
You may be eligible to participate if you are a pregnant woman who: • Is between 8-24 weeks gestation with a singleton pregnancy • Have type 1 diabetes for at least 12 months, or the father or a full sibling of the baby has type 1 diabetes • Is 18 years of age or older • Is wi... Protocol #: 22-1840 |
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A T cell phenotype signature driven dose finding study with siplizumab
in type 1 diabetes mellitus
Open label study in subjects age 8-45 with T1D diagnosis within 18 months to identify a safe and metabolically favorable dosing regimen of siplizumab. ... Protocol #: 22-0999 Location: Barbara Davis Center, University of Colorado Hospital |
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JAK Inhibitors to Preserve C-Peptide Production in New Onset T1D: A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subtype-Selective JAK Inhibitors for Preservation of Pancreatic β Cell Function in Newly Diagnosed Type 1 Diabetes Mellitus
This phase 2 trial is a double-blind, randomized, placebo-controlled clinical trial in male and female adolescent and adult participants (ages 12-35 years) with newly diagnosed Stage 3 T1D (within 100 days of diagnosis). Enrollment into abrocitinib and ritlecitinib arms and the shared ... Protocol #: 23-0996 Location: Barbara Davis Center, University of Colorado Hospital |
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Feasibility and Preliminary Efficacy of a Reverse Diet as a Novel Weight Loss Maintenance Strategy for Weight-Reduced Adults with Overweight/Obesity
In this study, we will be evaluating the effects of a reverse-diet compared to standard weight loss maintenance advice.... Protocol #: 17-1726 Location: Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital |
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Treating PCOS with Semaglutide 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 Location: Childrens Hospital Colorado, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital |
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Surgical or Medical Treatment for Pediatric Type 2 Diabetes
Surgical 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)... Protocol #: 19-1978 Location: Childrens Hospital Colorado, University of Colorado Hospital |
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Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents
Protocol #: 20-2649 Location: Children's Hospital National (CHN), Children's Hospital National (CHN), Childrens Hospital Colorado, Colorado State University, Uniformed Services University of Health Sciences (USUHS), Uniformed Services University of Health Sciences (USUHS) |
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A phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 400 mg twice a day oral ladarixin in patients with new-onset type 1 diabetes and a low residual β-cell function at baseline.
A phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 400 mg twice a day oral ladarixin in patients with new-onset type 1 diabetes and a low residual β-cell function at baseline. It has been designed to further evaluate whether la... Protocol #: 21-2474 Location: Barbara Davis Center, University of Colorado Hospital |
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Glucose Monitoring in Youth with Cystic Fibrosis During Pulmonary Exacerbations (GeM-PEx)
The purpose of this study is to determine if pulmonary exacerbations in youth with cystic fibrosis cause blood sugars to vary during and after an exacerbation. Blood sugars will be monitored using a continuous glucose monitor (CGM) for 2 weeks both during and 6 weeks after an exacerbation... Protocol #: 21-3666 Location: Childrens Hospital Colorado |
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Randomized, sham-controlled, multicenter, pragmatic, trial with open-label extension of PHOENIX to improve glycemic control in adults with type 2 diabetes in a real-world setting
BRIGHT - Digital therapeutic Based Randomized Investigation to improve Glycemic control in patients with type 2 diabetes and residual Hyperglycemia on stable medical Therapy
Randomized, sham-controlled, multicenter, pragmatic, pivotal trial with open-label extension evaluating the hypothesis that PHOENIX, an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control, will lower hemoglobin A1c (HbA1c) compa... Protocol #: 21-4891 Location: Boulder Health Center, Broomfield Hospital, Cherry Creek Medical Center, CTRC Inpatient, Highlands Ranch Hospital, Lone Tree Medical Center, Longs Peak Hospital, UCHealth Central Park Medical Center, UCHealth Internal Medical Clinic - Lowry, UCHealth Northfield Medical Center, UCHealth Steadman Hawkins Clinic - Denver (Inverness), University of Colorado Hospital |
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Libre 2 CGM plus Glycemic Excursion MIniMization (GEM) in the Treatment of PrEDiabeteE: The IMPEDE Study
For people with prediabetes, it may be possible to delay or prevent the progression to diabetes by reducing postprandial glucose (PPG). Our Glycemic Excursion Minimization (GEM) lifestyle intervention guide can reduce PPG in people with type 2 diabetes and has been studied in this populati... Protocol #: 21-4931 Location: Outpatient CTRC |
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GALAXY: Generating Advancements through Longitudinal Analysis in X and Y Syndromes
Participants who join the GALAXY Registry are agreeing to have their medical records be used for research. There are no additional study visits, etc. – participants just continue with their usual clinical care. If participants are seen outside of Children’s Colorado, they can sign a Releas... Protocol #: 20-0482 Location: Childrens Hospital Colorado, Outpatient CTRC |
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A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study with an Open-Label Extension Assessing the Efficacy, Safety, and Pharmacokinetics/Pharmacodynamics of Tirzepatide in Pediatric and Adolescent Participants with Type 2 Diabetes Mellitus Inadequately Controlled with Metformin, or Basal Insulin, or Both (SURPASS-PEDS)
Protocol #: 22-0513 Location: Childrens Hospital Colorado |
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TArgeting Type 1 Diabetes Using POLyamines (TADPOL): A Randomized, Double-Masked, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of Difluoromethylornithine (DFMO) to Preserve Insulin Production in Type 1 Diabetes
This study will be a multicenter, double-blind, placebo-controlled, 2:1 random assigned, phase II clinical trial for individuals with recent onset type 1 diabetes. We are conducting a double masked placebo-controlled intention to treat study enrolling persons with new onset T1D with docu... Protocol #: 23-0398 Location: Barbara Davis Center, University of Colorado Hospital |
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Safety and Efficacy of the Omnipod? 5 Automated Insulin Delivery System in Adults with Type 2 Diabetes
This single-arm, multi-center, prospective study will evaluate the safety (primary) and efficacy (secondary) of the Omnipod? 5 Automated Insulin Delivery System in adults with type 2 diabetes requiring insulin therapy.... Protocol #: 23-0388 Location: Anschutz Health and Wellness, Barbara Davis Center, Lone Tree Medical Center |