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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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Salmon intake and gut health in adults
You may be eligible if: - You are between 30 and 70 years old - Your BMI is between 25 and 40 (check with this BMI calculator https://www.nhlbi.nih.gov/health/educational/lose_wt/BMI/bmi-m.htm) - Exercise 3 hours/week or less - Not on any glucose lowering medications This study co... Protocol #: 20-1033 |
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Cardiovascular Mechanisms of Exercise Intolerance in Diabetes and the Role of Sex
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 #: 17-0356 |
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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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A Phase 3b/4, Double-masked, randomized, International, Parallel-assignment, Multicenter Trial in Patients with Thyroid Eye Disease to Evaluate the Safety and Tolerability of Different Dosing Durations of Teprotumumab Protocol Number: HZNP-TEP-402
Patients are “randomized” (assigned by chance) to receive one of the following study treatment lengths: • 4 infusions of TEPEZZA (teprotumumab) (Cohort [Group] 1), followed by either 4 infusions of TEPEZZA or 4 infusions of placebo (Placebo looks like the study drug, but does not inclu... Protocol #: 21-3831 |
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The Influence of Combined Oral Contraceptives on Weight: A 6-month Observational Study
Approximately 15 million women of reproductive age women in the United States have overweight or obesity and use the combined estrogen and progestin oral contraceptive pill (COC). Although many women report weight gain as a side effect of COCs, a conclusive link between COC use and weight ... Protocol #: 21-3969 Location: CTRC-adult, University of Colorado Hospital |
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PANTHER: Puberty, diAbetes, aNd THe kidnEys, when eustress becomes distress
The study visits will be at the outpatient Clinical & Translational Research Center (CTRC) at Children’s Hospital Colorado. This study takes place over 3 years. The day 1 and day 2 visits are the same each year and will take place approx. 12 months apart. ... Protocol #: 21-3019 Location: Childrens Hospital Colorado |
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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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A Randomized Parallel Comparison of Semaglutide versus Placebo on Intestinal Barrier (SIB)
Participants should be type 2 diabetic and be treated with metformin only. Each participant will complete 7-8 visits. After screening, participants will be given either semaglutide or a placebo and will be asked to self-administer the medication once weekly. Study visits will include blood... Protocol #: 21-2774 Location: CU Anschutz non-hospital research facilities |
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Tissue-specific effects of insufficient sleep
The 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-... Protocol #: 17-0533 Location: CTRC Inpatient, CTRC-UC Boulder, 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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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 |
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EnVision CF Multicenter Study of Glucose Tolerance in Cystic Fibrosis
The 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, an... Protocol #: 19-0422 Location: Childrens Hospital Colorado, 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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The Effects of Acute Resistance Exercise on Energy Balance Regulation among Breast Cancer Survivors
Exercise is important for weight management after treatment for breast cancer. This study aims to assess the effect of exercise on appetite and energy intake after breast cancer treatment. Participants will complete 3-5 study visits at the University of Colorado and receive monetary compen... Protocol #: 19-1974 Location: 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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The effects of hormone therapy on renal hemodynamic function in transgender youth
One screening visit to see if you are eligible to participate, then one study visit prior to starting testosterone or estradiol and one study visit 3 months later. ... Protocol #: 20-0572 Location: Childrens Hospital Colorado, Outpatient CTRC, Outpatient CTRC |
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Breaking up sedentary time to improve glucose control in a population at risk for developing type 2 diabetes
This randomized control trial examines differences in glycemia and insulin sensitivity, acute and 1-month glucose fluctuations and 1-month glucose disposal pathways between two physical activity strategies: BREAK and ONE. The BREAK strategy consists of 5-minute bouts of brisk walking perf... Protocol #: 20-1900 Location: Outpatient CTRC, University of Colorado Hospital |
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Disordered Eating, Energy Availability, and Quality of Life in Adolescent Athletes
Participants will receive a DEXA scan and will wear a FitBit for a week to track HR, sleep, and exercise. The participant will also log their food intake for the week. Compensation included. ... Protocol #: 20-1681 Location: Childrens Hospital Colorado, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital |
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Neuronal and behavioral effects of an implicit priming approach to improve eating behaviors in obesity
Study participants: -Will watch pictures of food during MRI recording, to measure brain responses to the pictures. -Will complete questionnaires related to food, activity, and mood. -Will complete a once-weekly intervention for 12 weeks that involves viewing food or food images. ... Protocol #: 20-2821 Location: Outpatient CTRC, Outpatient CTRC, 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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Assessing feasibility, safety, and efficacy of deploying a closed-loop automated insulin delivery system by community-based primary care physicians and academic endocrinologists, in person and through telehealth.
The purpose of this study is to learn more about the safety and effectiveness of the iLet - Bionic pancreas device for treating Type 1 diabetes when implemented in primary care and endocrinology, and both in-person and via telehealth.... Protocol #: 21-3272 Location: Department Specific Free Standing Clinic, Lone Tree Medical 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: University of Colorado Hospital |
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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. We are recruiting volunteers who experience PTSD-related nig... Protocol #: 21-5027 Location: Outpatient CTRC |
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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
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 #: 22-0325 Location: Harmony Campus, Medical Center of the Rockies |