Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05414409
Other study ID # 15498
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 28, 2022
Est. completion date August 1, 2026

Study information

Verified date May 2024
Source Indiana University
Contact Heba M Ismail
Phone 317-274-2114
Email heismail@iu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Obesity prevalence in persons with T1D has increased, which further complicates management and risk for complications. The proposed study is relevant to public health because it helps us understand the role of the gut microbiome in disease pathophysiology in T1D youth with obesity as well as potential mechanisms to modify disease.


Recruitment information / eligibility

Status Recruiting
Enrollment 114
Est. completion date August 1, 2026
Est. primary completion date August 1, 2026
Accepts healthy volunteers No
Gender All
Age group 11 Years to 18 Years
Eligibility Inclusion Criteria: 1. Obese youth 11-18 years of age with T1D at time of enrollment. 2. Lean youth 11-18 years of age with T1D at time of enrollment. Exclusion Criteria: 1. Known monogenic forms of diabetes or Type 2 diabetes (confirmed clinically and by genetic/antibody testing). 2. History of ongoing infection or antibiotic treatment within the past month; 3. History of immune-compromise, recurrent infections, steroid intake (inhaled or oral forms) or other immunosuppressant use in the past 6 months. 4. History of chronic gastrointestinal disease, possible or confirmed celiac disease; 5. Participation in any research intervention trials within the past 3 months. 6. History of treatment or use of metformin, a type 2 diabetes medication.

Study Design


Intervention

Drug:
Metformin
Metformin is an oral medication that improves insulin sensitivity.

Locations

Country Name City State
United States Indiana University School of Medicine Indianapolis Indiana

Sponsors (1)

Lead Sponsor Collaborator
Heba M. Ismail

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Differences in the gut microbiome in lean and obese youth with type 1 diabetes cross sectional comparison of stool microbiome using metagenomic sequencing data Baseline
Primary Differences in the gut microbial metabolites in lean and obese youth with type 1 diabetes The investigators will measure and compare the stool and serum short chain fatty acids using mass spectrometry Baseline
Primary Differences in the gut microbial metabolites in lean and obese youth with type 1 diabetes The investigators will measure and compare the stool and serum secondary bile acids using mass spectrometry Baseline
Primary Changes in the gut microbiome in obese youth with type 1 diabetes in response to metformin longitudinal comparison before and after taking metformin for 6 months, stool samples will be collected at baseline, 3 months and 6 months and sequenced for microbiome profile using metagenomic sequencing Baseline, Month 3, and Month 6
Primary Changes in the gut microbial metabolites in obese youth with type 1 in response to metformin The investigators will measure and compare the stool and serum metabolites (short chain fatty acids and secondary bile acids) before, during and after 6 months of daily metformin therapy using mass spectrometry Baseline, Month 3, and Month 6
Secondary Differences in measures of C-peptide as a measure of beta cell health in lean and obese T1D youth The investigators will measure serum C-peptide to calculate a ratio of proinsulin to C-peptide as a marker of beta cell health. These measures will then be compared between the lean and obese T1D youth. Baseline
Secondary Differences in measures Proinsulin as a measure of beta cell health in lean and obese T1D youth The investigators will measure serum proinsulin and calculate a ratio of proinsulin to C-peptide as a marker of beta cell health. These measures will then be compared between the lean and obese T1D youth. Baseline
Secondary Differences in measures of insulin sensitivity in lean and obese T1D youth Insulin sensitivity will be assessed in individuals using the estimated insulin sensitivity score (eIS), which is based on waist circumference (cm), HbA1c (%) and triglycerides (mg/dl) Baseline
Secondary Changes in measures of C-peptide as a measure of beta cell health in obese T1D youth in response to metformin Serum C-peptide will be used to calculate proinsulin to C-peptide ratio as a measure of beta cell health before and after metformin therapy Baseline, Month 3, and Month 6
Secondary Changes in measures of proinsulin as a measure of beta cell health in obese T1D youth in response to metformin Serum proinsulin will be used to calculate proinsulin to C-peptide ratio as a measure of beta cell health before and after metformin therapy Baseline, Month 3, and Month 6
Secondary Changes in measures of insulin sensitivity in obese T1D youth in response to metformin Estimated insulin sensitivity score will be used to assess response metformin therapy Baseline, Month 3, and Month 6
Secondary Changes in measures of beta cell function using a timed mixed meal tolerance test Participants in the metformin trial will undergo a standard 2-hour mixed meal tolerance test at baseline and after 6 months of oral metformin therapy Baseline and Month 6
See also
  Status Clinical Trial Phase
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2