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Explore actively recruiting studies pulled live from the public ClinicalTrials.gov registry. Filter by condition and state, then check your eligibility in under a minute.

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24 recruiting in CO
Recruiting

Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)

Type 2 Diabetes Mellitus Β· Diabetic Kidney Disease Β· Adolescent Obesity

Early diabetic kidney disease (DKD) occurs in 50-70% of youth with type 2 diabetes (T2D) and confers high lifetime risk of dialysis and premature death. Youth-onset T2D typically manifests during or shortly after puberty in adolescents with obesity. Epidemiological data implicate puberty as an accelerator of kidney disease in youth with obesity and diabetes and the investigators posit that the link between puberty and T2D-onset may explain the high burden of DKD in youth-onset T2D. A better understanding of the impact of puberty on kidney health is needed to promote preservation of native kidney function, especially in youth with T2D.

Aurora, CO8–14 yrsAll genders
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A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Alone or in Combination With Dapagliflozin Compared With Placebo in Adults With Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron alone or in combination with dapagliflozin compared with placebo in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication.

Englewood, CO18+ yrsAll genders
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Project Dulce for Arab Americans With Type 2 Diabetes

Diabetes Mellitus, Type 2

Arab Americans (AA) face many challenges in diabetes self-management due to the limited educational resources and support available for them. The cultural and linguistic barriers between patients and health care providers lead to poor diabetes management and outcomes. This study (Project Dulce Arabic) is adapted from the Project Dulce, an American Diabetes Association (ADA)-recognized Diabetes Self-Management Education Support (DSMES) program. Project Dulce Arabic comprises both peer-led diabetes education in Arabic and a 3-month text messaging program (Dulce Digital). The main aim of the study is to examine the effectiveness of a more culturally and linguistically appropriate diabetes education program in improving diabetes knowledge, beliefs, and self-management as well as hemoglobin A1C.

Denver, CO18+ yrsAll genders
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EASi-PROTKTβ„’ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease

Diabetes Mellitus, Type 2 Β· Hypertension Β· Cardiovascular Diseases

This study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin. Participants are put into 2 groups randomly, which means by chance. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets with empagliflozin. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take a tablet once per day for 2 and a half years and up to 4 years and 3 months. All participants also continue their medication for type 2 diabetes, high blood pressure, and cardiovascular disease. Participants have an equal chance of receiving the study medicine or placebo. Participants are in the study for up to 4 years and 3 months. During this time, they visit the study site regularly. During these visits, doctors collect information about participants' health and take blood samples. The doctors document when participants experience cardiovascular events. The doctors also regularly check participants' health and take note of any unwanted effects.

Aurora, Golden, CO18+ yrsAll genders
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Recruiting

Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery

Type 1 Diabetes (T1D) Β· Type 2 Diabetes Β· Diabetes, Autoimmune

The goal of this randomized controlled trial is to compare the efficacy and safety of the iLet Bionic Pancreas (BP) System in adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes) compared to standard of care when ordered by primary care providers. The main question it aims to answer is: Can the iLet BP by deployed in primary care settings to adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes)? Researchers will compare 13-weeks of iLet BP use to routine care to see if iLet BP use has a greater reduction in HbA1c compared to13-weeks of routine care. Participants will: Use the iLet BP for 13-weeks or continue their routine care Be trained to use the study devices or continue their routine care Complete a virtual screening visit, mid-period follow up calls and a final visit Complete baseline CGM collection Complete surveys and fingerstick a1c blood tests Routine care participants will have the option to complete an observational extension phase where they will wear the iLet BP for 13-weeks

Aurora, CO18–89 yrsAll genders
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Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification

Type 2 Diabetes

A Randomized Control Trial (RCT) with 1:1 randomization of adults newly diagnosed with type 2 diabetes (T2D) to Routine Care (RC) and RC + Glycemic Excursion Minimization (RC+GEM); a program that provides RC in addition to continuous glucose monitors (CGM) within a structured, self-directed, and personalized lifestyle program called GEM. Our hypothesis is that RC+GEM will: 1) reduce hemoglobin A1c as much or more, 2) require less diabetes medication, 3) cost less, and 4) have more secondary benefits, (e.g. greater reduction in cardiovascular risk, weight, diabetes distress, depression symptoms), compared to RC alone.

Aurora, CO30–80 yrsAll genders
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Cognitive-Behavioral Therapy and Exercise Training in Adolescents At-Risk for Type 2 Diabetes

Insulin Resistance Β· Depression Β· Depressive Disorder

The investigators are doing this study to learn more about how to prevent type 2 diabetes in teenage girls. The purpose of this study is to find out if taking part in a cognitive-behavioral therapy group, exercise training group, or a combination of cognitive-behavioral therapy and exercise training groups, decreases stress, improves mood, increases physical activity and physical fitness, and decreases insulin resistance among teenagers at risk for diabetes.

Aurora, Fort Collins, CO12–17 yrsWomen
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A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus on Background Insulin

Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults with Type 2 Diabetes Mellitus (T2DM), treated with a background insulin and other background glucose-lowering medication(s)

Aurora, CO18+ yrsAll genders
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A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DM

Weight Management

This master study protocol, Study D7260C00015, covers 2 independent, pivotal studies, Study 1 and Study 2. Each study is a global, randomized, double-blind, parallel-group, multicenter, Phase III study to assess the efficacy and safety of elecoglipron compared with placebo adjunct to diet and exercise for weight management, in adults living with obesity or overweight with at least one weight-related comorbidity, and without T2DM (Study 1) or with T2DM (Study 2).

Arvada, CO18+ yrsAll genders
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A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events

Diabetes Mellitus, Type 2 Β· PreDiabetes Β· Metabolic Syndrome

TRANSFORM is a prospective, randomized, open blinded endpoint (PROBE), event-driven, pragmatic trial in patients who are at increased risk for atherosclerotic cardiovascular (CV) disease but with no known symptomatic CV disease. The trial tests the hypothesis that a Cleerly Coronary Artery Disease (CAD) Staging System-based care strategy reduces CV events compared with risk factor-based care.

Aurora, Denver, CO55+ yrsAll genders
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Recruiting

SMART 2D: Study of Montelukast's Effects on Renal and Cardiovascular Health in Adolescents and Young Adults With Type 2 Diabetes

Type 2 Diabetes

Adolescents and young adults (AYA) with type 2 diabetes (T2D) have a more severe phenotype than what is seen in youth-onset type 1 diabetes or adult-onset T2D including earlier kidney and cardiovascular disease complications; and prioritizing new treatments, either for standalone use or in combination with other therapies is critical. T2D triggers the release of proinflammatory mediators called cysteinyl leukotrienes leading to damage to the kidneys and blood vessels. This clinical trial will evaluate the effects of montelukast, a cysteinyl leukotriene inhibitor, on kidney and vascular function in AYA with T2D to help direct future diabetes care to limit diabetic kidney and cardiovascular disease complications.

Aurora, CO14–24 yrsAll genders
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Platform Trial to Delay Stage 3 Diabetes: Comparing Teplizumab With ATG

Type 1 Diabetes Mellitus

This is a 2-arm, multi-center, open label study to learn if ATG works the same or better than teplizumab in delaying or preventing Stage 3 Type 1 diabetes. Participants will be administered either 2 infusions of ATG or 14 infusions of teplizumab and will then be followed for at least 12-48 months after administration, depending on timepoint enrolled into the study. If the primary endpoint demonstrates a positive signal and as decided by TrialNet, there is potential for a study extention. This would extend follow-up visits for a possible study duration of about 9 years among the earliest enrollees of the initial study.

Aurora, CO4–34 yrsAll genders
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Breaking up Sedentary Time to Improve Glucose Control in a Population at Risk for Developing Type 2 Diabetes

Pre-diabetes

Newly released guidelines recommend increased physical activity (PA) and reduced sedentary behaviors (SB) to improve glycemia and prevent the onset and progression of type 2 diabetes (T2D). Typically, 30-60 min bouts of PA are advocated per day. Although this approach increases PA, it does not decrease the length of the sedentary periods through the day. This is important because recent epidemiological data suggest that frequently interrupting sedentary time improves glucose control even in people who achieve the recommended levels of PA. Preliminary experimental data suggest that breaking up prolonged sedentary time by performing multiple short bouts (5 min) of PA throughout the day, may improve glycemia more than performing a single continuous bout of PA, and thereby potentially be a novel strategy to prevent T2D. The improvement in glycemia was observed even when the total amount of PA and total energy expenditure were matched, suggesting that how and when PA is performed over the day may matter more than how much PA is done. However, important gaps in knowledge remain including: (1) whether similar benefits on glucose control would be observed in adults with prediabetes, a clinically relevant population that is at high risk of developing T2D; (2) whether these effects are sustained or diluted over time, and (3) what are the mechanistic underpinnings. To address these gaps, the investigators propose to measure the acute and chronic effects of PA breaks on glucose control and the underlying mechanisms in individuals at risk of developing T2D. Sedentary men and women with prediabetes (n=66, 50% F) will be randomized to either an intervention designed to interrupt SB with 5-min bouts of brisk walking performed hourly for 9 hours/day, 5 days/week (BREAK) or a control condition consisting of 45-min of brisk walking performed as a single daily continuous bout, 5 days/week (ONE). The two 3-months interventions will be matched for total active time.

Aurora, CO18–64 yrsAll genders
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Recruiting

Role of Microvascular Insulin Resistance and Cardiorespiratory Fitness Diabetes

Type 2 Diabetes Β· Overweight and Obesity

The goal of this two-site grant proposal is to determine the role of the decreased insulin-mediated muscle perfusion found in type 2 diabetes in contributing to the development of cardiac and skeletal muscle dysfunction and subsequent functional exercise impairment. In addition, it is also our goal to determine whether exercise training attenuates insulin resistance and restores insulin-mediated perfusion to the heart and to skeletal muscle, leading to improved cardiac function and exercise performance.

Aurora, CO30–55 yrsAll genders
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A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight

Obesity Β· Type 2 Diabetes

This clinical study is testing how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes (T2D), lose weight. The purpose of the study is to find out how safe and effective CagriSema is for body weight loss in these participants. Participants will receive either CagriSema or semaglutide, and which treatment participants receive is decided by chance. CagriSema is a new study medicine being tested, while semaglutide is a medicine that doctors can already prescribe. The study will last for about 83 weeks

Aurora, CO18+ yrsAll genders
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