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Skeletal Muscle Health in Children With Type 1 Diabetes

NCT04288063 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 29

Last updated 2023-12-11

No results posted yet for this study

Summary

The purpose of this research study is to find out if Type 1 Diabetes (T1D) affects skeletal muscle health and if we can improve glycemic control by improving skeletal muscle health. Participants in this study will have a blood sample and a urine sample collected after taking a single dose of a nontoxic chemical called D3-creatine. Their body composition will be measured by a scale like device. Parents of participating children will also be asked to complete a food and activity questionnaire.

Participants will be in the study for roughly 12 to 24 months. Enrollment will begin once participant signs the consent form. At the 12 month follow-up visit participants will be asked to wear a Garmin physical activity monitor and use the Garmin Connect mobile app for a period of up to 12 months and take a one time Muscle Strength Measurement test.

The greatest risks of this study include the possibility of loss of confidentiality.

Conditions

Sponsors & Collaborators

Principal Investigators

  • Pinar Gumus Balikcioglu, MD · Duke University

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-18
Primary Completion
2022-10-31
Completion
2023-11-19

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04288063 on ClinicalTrials.gov