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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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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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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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A Phase IIa, randomized, double-blind placebo-controlled, dose comparison, multi-centre adaptive design clinical trial to evaluate the immune signature of the treatment with the Imotope IMCY-0098 and its effect on the preservation of beta-cell function in adult patients with a recent onset Type 1 diabetes
Subcutaneous injections of IMCY-0098 or placebo every 2 weeks, for a total of 7 injections... Protocol #: 22-0478 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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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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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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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, Outpatient CTRC, 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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Investigator- and subject-blinded, randomized, placebo-controlled study to evaluate safety, tolerability, pharmacokinetics and efficacy of CFZ533 in pediatric and young adults with new onset type 1 diabetes mellitus (T1DM)
1st treatment of study drug or placebo given by IV infusion Weekly subcutaneous injections of study drug or placebo for 1 year (52 weeks) Completion of a study diary to record insulin dose, and hypoglycemic events CGM measurements 8 mixed-meal tolerance tests (MMTTs): a test where the... Protocol #: 22-0191 Location: Barbara Davis Center, Childrens Hospital Colorado, 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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BRIGHT- Randomized, sham-controlled, multicenter, pragmatic, trial with open-label extension of BT-100 to improve glycemic control in adults with type 2 diabetes
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 |
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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, Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Paltusotine
in Subjects with Non-pharmacologically Treated Acromegaly
The purpose of this study is to see if the Sponsor’s investigational (research) medication called paltusotine is tolerable, safe, and effective in controlling the growth hormone (GH) levels of patients with acromegaly. GH acts on many parts of the body to promote growth in children. Onc... Protocol #: 22-1406 Location: Outpatient CTRC, University of Colorado Hospital |
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Protocol Title: Efficacy and safety of cagrilintide s.c. 2.4 mg in combination with semaglutide
s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) once-weekly in participants with overweight or
obesity (Study ID: NN9838-4608)
Participants will be randomly assigned to one of four treatment options (CagriSema, or Cagrilintide alone, Semaglutide alone, or placebo) and will receive monthly dietary counseling during the 75 week main study.... Protocol #: 22-1393 Location: Anschutz Health and Wellness, Outpatient CTRC |