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

NCT03199638 | Completed Results

• 1 other identifier: Nemours IRB #790908
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus, Type 1; Autoimmune Diseases; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Immune System Diseases; Metabolic Diseases

Keywords

Continuous Glucose Monitoring; Children; Exercise; Glycated hemoglobin; Adolescents; Insulin sensitivity; Glutamine

Outcome Measures

Primary Outcomes (1)

• HbA1c, Glycated Hemoglobin

  change in glycated hemoglobin

  baseline vs. at 3 months

Secondary Outcomes (6)

• Change in the Mean Amplitude of Glycemic Excursions (MAGE)

  before vs. at 3 months

• Change in Percent of Blood Glucose (BG) Within Target

  baseline vs. at 3 months

• Percent of BG <70 mg/dL

  baseline vs. at 3 months

• Percent Blood Glucose (BG) >180

  baseline vs. at 3 months

• Insulin Dose

  baseline vs. at 3 months

Study Arms (2)

an exercise group

EXPERIMENTAL

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);

Behavioral: Exercise

an exercise + glutamine group

EXPERIMENTAL

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

Drug: Glutamine vs. Placebo; Behavioral: Exercise

Interventions

Glutamine vs. Placebo DRUG

oral supplementation with either glutamine or placebo twice daily for 3 months

an exercise + glutamine group

Exercise BEHAVIORAL

short bouts of exercise ('exercise snacks') 3 times daily for 3 months

an exercise + glutamine group; an exercise group

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Related Publications (31)

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MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Autoimmune Diseases; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Immune System Diseases; Metabolic Diseases; Motor Activity; Insulin Resistance

Interventions

Exercise

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Behavior; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr Dominique Darmaun, PI
• Organization: Nemours Children's Health

ddarmaun@nemours.org

904 6973674

Study Officials

• Dominique Darmaun, PhD, MD

  Nemours Children's Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 27, 2017
• Study Start: April 1, 2016
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: August 14, 2023
• Results First Posted: August 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)