Glutamine and Insulin Sensitivity in Type I Diabetes
Primary Purpose
Type I Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Glutamine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type I Diabetes Mellitus focused on measuring Type I Diabetes, Insulin Resistance, Glutamine, Amino Acids, Glucagon like peptide 1, Glutathione, Citrulline, Arginine, Nitric Oxide
Eligibility Criteria
Inclusion Criteria:
- Type I diabetes diagnosed for > 12 months.
- Minimal weight of 40 kg
- Tanner stage IV or beyond
- All insulin programs, including intermediate/short acting insulins, Lantus/Detemir and short acting insulin or insulin pump therapy.
- HbA1C between 7.5 and 10%
- BMI between 10th to 85th percentile
- Patients on stable thyroid replacement therapy will be allowed to participate.
Exclusion Criteria:
- Celiac disease (any patient with history of positive serology or consuming a gluten-free diet)
- Cystic Fibrosis
- Chronic steroid therapy
- Chronic medications that may interfere with glucose metabolism or liver function
- History of mental retardation
- Presence of diabetic complications
- Positive pregnancy test
- Presence of significant anemia (Hb<11 g/dL)
- Presence of intercurrent infection
Sites / Locations
- Nemours Children's Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Glutamine
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Insulin Sensitivity
Insulin sensitivity as measured by hyperinsulinemic-euglycemic clamp. Insulin sensitivity was calculated by dividing the average glucose infusion rate (mL glucose infusion/kg body weight/min) by the average insulin concentration (uU/mL).
Secondary Outcome Measures
Glucagon-like Peptide 1 (GLP-1)
Full Information
NCT ID
NCT01467063
First Posted
November 2, 2011
Last Updated
July 12, 2021
Sponsor
Nemours Children's Clinic
Collaborators
Thrasher Research Fund
1. Study Identification
Unique Protocol Identification Number
NCT01467063
Brief Title
Glutamine and Insulin Sensitivity in Type I Diabetes
Official Title
Dietary Amino Acids and Insulin Sensitivity in Children With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nemours Children's Clinic
Collaborators
Thrasher Research Fund
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Insulin is crucial to help the body metabolize ('burn') sugar (glucose). Even though juvenile (type 1) diabetes (T1D) is primarily due to the lack of insulin, patients with T1D tend to become less sensitive to insulin, particularly during adolescence.
The overall objective of this project is to gain further insight into the possible benefits of supplementation with glutamine (GLN), a natural dietary amino acid, enhancing insulin sensitivity in adolescents with T1D. To elucidate the impact of glutamine, the investigators will use a method called the 'euglycemic, hyperinsulinemic clamp': it consists of giving an IV drip of insulin, while the drop in blood sugar is prevented by giving variable, precisely measured amounts of glucose by vein: the amount of glucose required to prevent a drop in blood sugar reflects the body's sensitivity to insulin. The investigators will also give an IV drip of glucose and arginine (a building block of protein) 'tagged' with non-radioactive isotopes to better understand how glutamine may work. This procedure will be performed in 2 groups of 10 adolescents in the morning either after a strenuous exercise performed the previous afternoon (group 1; n=10), or after a sedentary day (group 2; n=10). Each subject will be studied twice, once after taking oral GLN, once after placebo, in separate clinical research center (CRC) admissions a few weeks apart, in random order.
Should the investigators hypothesis prove to be true, it would warrant long term studies to determine whether sustained dietary GLN supplementation can decrease insulin requirements and ultimately improve diabetes control in teenagers with T1DM, If successful, this approach could potentially have a significant positive impact in terms of adolescent health.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type I Diabetes Mellitus
Keywords
Type I Diabetes, Insulin Resistance, Glutamine, Amino Acids, Glucagon like peptide 1, Glutathione, Citrulline, Arginine, Nitric Oxide
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glutamine
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Glutamine
Intervention Description
Participants will keep a diary of food intake and activity as well as wear an accelerometer (to measure overall movement) for 2-3 days prior to the admission. Subject will come to the Clinical Research Center for approximately 24 hours. They will receive a drink containing Glutamine (0.25 g/kg/dose). Afterwards they will have an afternoon exercise session consisting of 15-min bouts of exercise, interspersed with 5-min rest periods in between for a total of 75min. Blood glucose will be checked during rest intervals. They will be served a controlled dinner. Before bedtime another dose of the same drink will be given. Overnight blood glucose will be monitored closely. In the morning, another dose of the same drink will be given. Subjects will have two isotope infusions (non-radioactive) running concomitantly and a hyperinsulinemic-euglycemic clamp will be performed. Afterwards lunch will be served and subject discharged home.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Participants will keep a diary of food intake and activity as well as wear an accelerometer (to measure overall movement) for 2-3 days prior to the admission. Subject will come to the Clinical Research Center for approximately 24 hours. They will receive a PLACEBO drink. Afterwards they will have an afternoon exercise session consisting of 15-min bouts of exercise, interspersed with 5-min rest periods in between for a total of 75min. Blood glucose will be checked during rest intervals. They will be served a controlled dinner. Before bedtime another dose of the same drink will be given. Overnight blood glucose will be monitored closely. In the morning, another dose of the same drink will be given. Subjects will have two isotope infusions (non-radioactive) running concomitantly and a hyperinsulinemic-euglycemic clamp will be performed. Afterwards lunch will be served and subject discharged home.
Primary Outcome Measure Information:
Title
Insulin Sensitivity
Description
Insulin sensitivity as measured by hyperinsulinemic-euglycemic clamp. Insulin sensitivity was calculated by dividing the average glucose infusion rate (mL glucose infusion/kg body weight/min) by the average insulin concentration (uU/mL).
Time Frame
During the Hyperinsulinemic-Euglycemic Clamp, an average of 3 hours
Secondary Outcome Measure Information:
Title
Glucagon-like Peptide 1 (GLP-1)
Time Frame
Post-Infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type I diabetes diagnosed for > 12 months.
Minimal weight of 40 kg
Tanner stage IV or beyond
All insulin programs, including intermediate/short acting insulins, Lantus/Detemir and short acting insulin or insulin pump therapy.
HbA1C between 7.5 and 10%
BMI between 10th to 85th percentile
Patients on stable thyroid replacement therapy will be allowed to participate.
Exclusion Criteria:
Celiac disease (any patient with history of positive serology or consuming a gluten-free diet)
Cystic Fibrosis
Chronic steroid therapy
Chronic medications that may interfere with glucose metabolism or liver function
History of mental retardation
Presence of diabetic complications
Positive pregnancy test
Presence of significant anemia (Hb<11 g/dL)
Presence of intercurrent infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Darmaun, MD, PhD
Organizational Affiliation
Nemours Children's Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20585005
Citation
Mauras N, Xing D, Fox LA, Englert K, Darmaun D. Effects of glutamine on glycemic control during and after exercise in adolescents with type 1 diabetes: a pilot study. Diabetes Care. 2010 Sep;33(9):1951-3. doi: 10.2337/dc10-0275. Epub 2010 Jun 28.
Results Reference
background
PubMed Identifier
28063503
Citation
Torres-Santiago L, Mauras N, Hossain J, Weltman AL, Darmaun D. Does oral glutamine improve insulin sensitivity in adolescents with type 1 diabetes? Nutrition. 2017 Feb;34:1-6. doi: 10.1016/j.nut.2016.09.003. Epub 2016 Sep 20.
Results Reference
result
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Glutamine and Insulin Sensitivity in Type I Diabetes
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