Diabetes Mellitus Clinical Trial
Official title:
Exercise Snacks and Glutamine to Improve Glucose Control in Adolescents With Type 1 Diabetes
Verified date | July 2023 |
Source | Nemours Children's Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 14 |
Est. completion date | June 30, 2017 |
Est. primary completion date | June 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 19 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Nemours Children's Clinic | Jacksonville | Florida |
Lead Sponsor | Collaborator |
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Nemours Children's Clinic |
United States,
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* Note: There are 31 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HbA1c, Glycated Hemoglobin | change in glycated hemoglobin | baseline vs. at 3 months | |
Secondary | Change in the Mean Amplitude of Glycemic Excursions (MAGE) | MAGE describes the average amplitude of glycemic variations measured using continuous glucose monitoring (CGM) | before vs. at 3 months | |
Secondary | Change in Percent of Blood Glucose (BG) Within Target | Percent of BG between 70 and 180 mg/dL, as measured using Continuous Glucose Monitor (CGM) | baseline vs. at 3 months | |
Secondary | Percent of BG <70 mg/dL | Change in Percent of BG below 70 mg/dL, as determined by Continuous Glucose Monitor (CGM) | baseline vs. at 3 months | |
Secondary | Percent Blood Glucose (BG) >180 | Change in Percent of BG above 180 mg, as determined using Continuous Glucose Monitor (CGM) | baseline vs. at 3 months | |
Secondary | Insulin Dose | Change in insulin dose (Units/kg/day) used at home | baseline vs. at 3 months | |
Secondary | Insulin Sensitivity Score (ISS) | Change in insulin sensitivity score, determined using SEARCH ISS model published equation: logeIS = 4.64725 - 0.02032 × (waist, cm) - 0.09779 × (HbA1c, %) - 0.00235 × (Triglycerides, mg/dL). The range of ISS scores is between 1-15. Higher scores imply a better insulin sensistivity. | baseline vs. at 3 months |
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