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

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ClinicalTrials.gov Identifier: NCT03199638
Recruitment Status : Unknown
Verified June 2017 by Dominique Darmaun, Nemours Children's Clinic.
Recruitment status was:  Recruiting
First Posted : June 27, 2017
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Dominique Darmaun, Nemours Children's Clinic

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, we 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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Drug: Glutamine vs. Placebo Other: Exercise Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Exercise Snacks and Glutamine to Improve Glucose Control in Adolescents With Type 1 Diabetes
Study Start Date : April 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Glutamine

Arm Intervention/treatment
Experimental: 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);
Other: Exercise
short bouts of exercise ('exercise snacks') 3 times daily for 3 months

Experimental: 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
Drug: Glutamine vs. Placebo
oral supplementation with either glutamine or placebo twice daily for 3 months

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

No Intervention: control group
in which we will use historic data from previous study ("Statins in children with type 1 diabetes: effects on metabolism, inflammation and endothelial function) by choosing 12 children between 13-19 years with type 1 diabetes and meeting the very same inclusion/ exclusion criteria. We have readily available data for their HbA1C, CGM downloads, all labs and anthropometry for 3 months. We will select age, gender, and HbA1c-matched adolescents as these data were prospectively collected.



Primary Outcome Measures :
  1. Changes in HbA1C [ Time Frame: baseline vs. 3 months ]
  2. Changes in MAGE [ Time Frame: baseline vs. at one month and 3 months ]
    CGM data will be downloaded and used to calculate % blood glucose (BG) at, below or above target and the mean amplitude of glycemic excursions using a SAS program (MAGE)

  3. Changes in % BG at target (70-180), below target (<70), above target (>180) [ Time Frame: baseline vs. at one month and 3 months ]
  4. Changes in ISS [ Time Frame: baseline vs. at one month and 3 months ]
    An insulin sensitivity score (ISS) will be calculated as previously described using the SEARCH ISS model: logeIS = 4.64725 - 0.02032 (waist, cm) - 0.09779(HbA1c, %) - 0.00235(TG, mg/dl) (R2=0.74 in the initial SEARCH model) .This has been validated using the hyperinsulinemic euglycemic clamp, considered the gold standard for insulin sensitivity measures

  5. Changes in total insulin dosing (units/kg/day) [ Time Frame: baseline vs. at one month and 3 months ]


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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199638


Contacts
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Contact: Reham Hasan, MD 904-755-3542 rh0023@nemours.org
Contact: Kaitlin Sikes, ARNP 904-697-3988 ksikes@nemours.org

Locations
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United States, Florida
Nemours Children's Clinic Recruiting
Jacksonville, Florida, United States, 32207
Contact: Reham Hasan, MD    904-755-3542    rh0023@nemours.org   
Principal Investigator: Dominique Darmaun, MD, PhD         
Sub-Investigator: Nelly Mauras, MD         
Sub-Investigator: Reham Hasan, MD         
Nemours Children's Clinic Recruiting
Jacksonville, Florida, United States, 32207
Contact: Reham Hasan, MD    904-755-3542    rh0023@nemours.org   
Contact: Kaitlin Sikes, ARNP    904-697-3988    ksikes@nemours.org   
Sponsors and Collaborators
Nemours Children's Clinic
Investigators
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Principal Investigator: Dominique Darmaun, PhD, MD Nemours Children's Health System

Publications of Results:

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Responsible Party: Dominique Darmaun, Principal Investigator, Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT03199638     History of Changes
Other Study ID Numbers: Nemours IRB #790908
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dominique Darmaun, Nemours Children's Clinic:
Continuous Glucose Monitoring
Children
Exercise
Glycated hemoglobin
Adolescents
Insulin sensitivity
Glutamine
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Metabolic Diseases
Glucose Metabolism Disorders
Autoimmune Diseases
Immune System Diseases
Endocrine System Diseases