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N/A N=14 Randomized Triple-blind Treatment

Exercise Snacks and Glutamine to Improve Glucose Control in Adolescents With Type 1 Diabetes

Diabetes Mellitus, Type 1 · Autoimmune Diseases · Diabetes Mellitus · Endocrine System Diseases · Glucose Metabolism Disorders

Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: HbA1c, Glycated Hemoglobin — 7.9; 8.3; 8.0; 8.4 percentage of total hemoglobin

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Glutamine vs. Placebo (Drug); Exercise (Behavioral)
Age
Pediatric, Adult · 13+ yrs
Sex
All
Sponsor
Nemours Children's Clinic
Primary completion
Jun 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
HbA1c, Glycated Hemoglobin
7.9; 8.3; 8.0; 8.4
SECONDARY
Change in the Mean Amplitude of Glycemic Excursions (MAGE)
129; 108; 139; 123
SECONDARY
Change in Percent of Blood Glucose (BG) Within Target
63.7; 57.6; 46.4; 69.2
SECONDARY
Percent of BG <70 mg/dL
7.2; 3.1; 7.2; 4.4
SECONDARY
Percent Blood Glucose (BG) >180
29.1; 39.4; 46.4; 26.6
SECONDARY
Insulin Dose
1.0; 0.98; 0.8; 1.0
SECONDARY
Insulin Sensitivity Score (ISS)
2.17; 2.10; 2.20; 2.16

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

Eligibility Criteria

Inclusion Criteria

  • Type 1 diabetes for >12 months
  • Age between 13 and 19 years
  • Males and females at Tanner stage 4 and 5
  • All insulin programs, including intermediate,short acting insulin, Lantus, Detemir and short acting insulin or insulin pump therapy.
  • Weight of 40 kilograms or higher.
  • Hemoglobin A1C between 7%-10% and total daily insulin dose at least 0.9 unit/kg/day.
  • BMI between 10 centile to less than 95 percentiles.
  • Patients on stable thyroid replacement therapy will be allowed to participate. Exclusion Criteria
  • Celiac disease.
  • Cystic Fibrosis
  • Chronic steroid therapy
  • Chronic medications that may interfere with glucose metabolism or liver function.
  • History of mental retardation
  • Presence of diabetic complications
  • Being pregnant or having positive pregnancy test at any time during the study.
  • Presence of significant anemia (hemoglobin less than11 g/dL)
  • Presence of intercurrent infection
  • Subjects involved in an active exercise program or in an organized sport team
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03199638). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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