Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05720377
Other study ID # IRB-300007608
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date February 1, 2024
Est. completion date December 31, 2027

Study information

Verified date April 2023
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the use of an exercise phone application and a continuous glucose monitor and their impact on metabolic disease in adolescents with obesity, prediabetes and Type 2 diabetes. Participants will be asked to wear a continuous glucose monitor (Freestyle Libre) and if they are in the intervention group also participate in using an exercise phone application as well as have scheduled interval contact with a health professional in between scheduled clinic visits to assess how they are reaching their goals.


Description:

Patients will be recruited directly from the Childrens of Alabama pediatric endocrine clinic. Thirty patients who have obesity, prediabetes or Type 2 diabetes will be enrolled. During the enrollment phase, flyers will be posted in clinic and emails will be distributed to potential participants. Our study team will approach interested participants during their routine clinic visit. Consent will be obtained by study team during their endocrine clinic visit. Review of their medical records will be done and age, gender and race will be extracted from the medical record. A baseline visit with vital signs, blood work, a physical exam and nutritional counseling will be completed. Once enrolled, the patients will then be randomized.Within this pilot trial, we will randomize 15 adolescents/teenagers who either have obesity, prediabetes or Type 2 diabetes, to access to an exercise regimen and 15 adolescents to control intervention using a permuted block randomization scheme. The randomization scheme will contain 6 blocks of size 5 allowing for 30 randomized in the group with obesity, prediabetes and Type 2 diabetes. Those who are in the intervention group will then be given access to frequent telephone counseling to follow-up their nutrition and exercise goals, access to exercise application and accelerometer as described below. Follow-up will then be completed at 3 and 6 months with a physical exam, vital signs, blood draw. Intervention Group Access provided to exercise application Provided with Fitbit to wear and measure activity Weekly check-in with provider to determine how exercise goals have been that week. If unable to reach, we will text securely a clinic check-in and provide a healthy tip of the week. Meeting with nutrition at Baseline visit Continuous glucose monitor provided (plan to wear for 14 days during each month) Non-Intervention Group Meeting with nutrition at Baseline visit Continuous glucose monitor provided (plan to wear for 14 days at baseline visit, 3 month visit and 6 month visit)


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 31, 2027
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 17 Years
Eligibility Inclusion Criteria for Type 2 diabetes arm - BMI > 95th percentile - A1c> 6.5% - Age 14-17 (2 years post-menarchal) Inclusion for Prediabetes Arm - Age 14-17 (2 years post-menarchal) - A1c 5.7-6.4% Inclusion for Obesity Arm - Age 14-17 (2 years post-menarchal) - A1c 5.7-6.4% Exclusion Criteria for all arms - BMI <95th percentile - Specific obesity syndrome - Inability to participate in exercise workouts

Study Design


Related Conditions & MeSH terms


Intervention

Device:
continuous glucose monitor (Freestyle Libre
15 minute phone interview by health care provider to assess health goals set at clinic visits.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama at Birmingham

Outcome

Type Measure Description Time frame Safety issue
Primary skin fold thickness reliable estimate of subcutaneous fat at various sites of the body baseline
Primary skin fold measurement reliable estimate of subcutaneous fat at various sites of the body 3 month
Primary skin fold measurement reliable estimate of subcutaneous fat at various sites of the body 6 month
Primary Body mass index measure of body fat based on height and weight baseline
Primary Body mass index measure of body fat based on height and weight 3 month
Primary Body Mass Index measure of body fat based on height and weight 6 month
Secondary TNF-alpha inflammatory marker in the blood baseline
Secondary TNF-alpha inflammatory marker in the blood 3 months
Secondary TNF-alpha inflammatory marker in the blood 6 months
Secondary IL-6 inflammatory marker in the blood Baseline
Secondary IL-6 inflammatory marker in the blood 3 months
Secondary IL-6 inflammatory marker in the blood 6 months
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