Exercise Snacks and Glutamine to Improve Glucose Control in Adolescents With Type 1 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Nemours Children's Clinic
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- HbA1c, Glycated Hemoglobin
Study Overview
Brief 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
Detailed Description
This protocol will help determine whether 'exercise snacks', alone or in combination with dietary glutamine improves diabetes control in adolescents with type 1 diabetes.
All subjects for group A and B will have a full physical exam including Tanner staging as well as waist circumference measurement. A HbA1c, will be obtained as well as fasting triglycerides. A continuous glucose monitor (CGM IPro®, Medtronic Minimed, or a DexCom ^4) will be worn blindly for 6 days and data downloaded. Subjects will then be randomized to 2 study groups of 12 patients each:
(A) an 'exercise group', 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); (B) an 'exercise + glutamine group', 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.
Randomization to the exercise + placebo or the exercise + glutamine group or no exercise+ no glutamine supplements will be stratified according to HbA1c range (eg, 7.0-7.4%; 7.5-8.0 %; 8.4-9.0%;9.5-10%), so as to ensure the comparability of groups.
The placebo and glutamine drink will be prepared at home using measured doses of glutamine or placebo powder to be mixed in a calorie-free, flavored soft drink tailored to the child's individual taste. Patients, families and investigators will be blinded as to the contents of the supplement. Exercise snacks will be designed to be feasible using 6 min worth of simple resistance activities (SRA's) designed by the exercise physiology consultants, Drs. Churilla and Hawley. They may spread them throughout the day if needed. These will consist of activities such as alternating half-squats, calf raises, brief gluteal contractions and knee raises by using stretching bands. The tension of bands may be adjusted as needed during the study. A short video has been created showing the participants how to conduct these exercises and these will be updated periodically in order to keep their interest and compliance. An accelerometer will not be used given the short nature of these bouts of exercise. These will be completed 30 min before breakfast, lunch and dinner.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 13 Years to 19 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Arms & Interventions
an exercise + glutamine group
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
Intervention: Exercise (Behavioral)
an exercise group
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);
Intervention: Exercise (Behavioral)
an exercise + glutamine group
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
Intervention: Glutamine vs. Placebo (Drug)
Outcomes
Primary Outcomes
HbA1c, Glycated Hemoglobin
Time Frame: baseline vs. at 3 months
change in glycated hemoglobin
Secondary Outcomes
- Insulin Dose(baseline vs. at 3 months)
- Change in the Mean Amplitude of Glycemic Excursions (MAGE)(before vs. at 3 months)
- Percent of BG <70 mg/dL(baseline vs. at 3 months)
- Insulin Sensitivity Score (ISS)(baseline vs. at 3 months)
- Change in Percent of Blood Glucose (BG) Within Target(baseline vs. at 3 months)
- Percent Blood Glucose (BG) >180(baseline vs. at 3 months)
Investigators
Dominique Darmaun
Principal Investigator
Nemours Children's Clinic