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an exercise group for Diabetes

N/A
Waitlist Available
Led By Dominique Darmaun, PhD, MD
Research Sponsored by Nemours Children's Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Type 1 diabetes for >12 months
Age between 13 and 19 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before vs. at 3 months
Awards & highlights

Study Summary

This project will assess the feasibility and efficacy of the use of exercise and dietary supplementation with a non essential amino acid - glutamine - a component of most protein supplements, on the regulation of plasma glucose homeostasis in a clinical setting of children with type 1 diabetes (T1D). The study specifically targets patients in puberty as this period is associated with a physiological decline in insulin sensitivity, the latter often associated with poor control. Although physical exercise has long been known to exert beneficial effects on metabolism, lack of time is the most common reason perceived as preventing the performance of exercise in both healthy and diabetic subjects. In earlier studies, the investigators showed that oral supplementation with glutamine, a non essential amino acid given prior to exercise decreases overnight post-exercise blood glucose in adolescents with T1D. Hence, the objective of the current study is to investigate if a novel way of exercising, such as performing 6 short bouts of just 1 min each of intense exercise ('exercise snacks') 30 min before meals, with or without glutamine, improves glycemic control in adolescents with T1D. Designing innovative ways to improve diabetes control in adolescents is highly desirable. The specific aim of the project is to determine whether the sustained use of the proposed exercise snacks with or without glutamine results in diminished glycemic variability and/or improved glucose control

Eligible Conditions
  • Diabetes
  • Endocrine Disorders
  • Type 1 Diabetes
  • Immune System Disorders
  • Autoimmune Diseases
  • Metabolic Diseases

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline vs. at 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline vs. at 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
HbA1c, Glycated Hemoglobin
Secondary outcome measures
Change in Percent of Blood Glucose (BG) Within Target
Change in the Mean Amplitude of Glycemic Excursions (MAGE)
Insulin Dose
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: an exercise groupExperimental Treatment1 Intervention
in which subjects will perform daily 'exercise snacks' within 30 min before breakfast, lunch, and/or dinner or bedtime snack, along with a placebo drink which will be given before breakfast and dinner (twice daily);
Group II: an exercise + glutamine groupExperimental Treatment2 Interventions
in which subjects will receive a glutamine drink (0.25 g/kg per dose) before breakfast and dinner (twice daily), and perform 'exercise snacks' before each meal
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise
2016
Completed Phase 1
~760
L-Glutamine
FDA approved

Find a Location

Who is running the clinical trial?

Nemours Children's ClinicLead Sponsor
124 Previous Clinical Trials
18,117 Total Patients Enrolled
Dominique Darmaun, PhD, MDPrincipal InvestigatorNemours Children's Health System

Frequently Asked Questions

~2 spots leftby Apr 2025