Glutamine and Insulin Sensitivity in Type I Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Dominique Darmaun, Nemours Children's Clinic
ClinicalTrials.gov Identifier:
NCT01467063
First received: November 2, 2011
Last updated: May 2, 2013
Last verified: May 2013

November 2, 2011
May 2, 2013
October 2011
June 2013   (final data collection date for primary outcome measure)
Insulin Sensitivity [ Time Frame: 1 month ] [ Designated as safety issue: No ]
To determine whether dietary amino acids such as glutamine supplementation, enhance either peripheral or hepatic insulin sensitivity in adolescents with type 1 diabetes mellitus (T1D)
Same as current
Complete list of historical versions of study NCT01467063 on ClinicalTrials.gov Archive Site
Glutamine mechanism of action [ Time Frame: 1 month ] [ Designated as safety issue: No ]

To determine whether glutamine supplementation

  1. enhances citrulline, arginine, and nitric oxide (NO) production;
  2. increases glutathione (GSH) availability; and
  3. increases glucagon-like peptide 1 (GLP-1) secretion.
Same as current
Not Provided
Not Provided
 
Glutamine and Insulin Sensitivity in Type I Diabetes
Dietary Amino Acids and Insulin Sensitivity in Children With Type 1 Diabetes

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Type I Diabetes Mellitus
  • Dietary Supplement: Glutamine
    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.
  • Dietary Supplement: Placebo
    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.
  • Active Comparator: Glutamine
    Intervention: Dietary Supplement: Glutamine
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
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. Epub 2010 Jun 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
July 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
13 Years to 19 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01467063
IRC# 11-29
No
Dominique Darmaun, Nemours Children's Clinic
Nemours Children's Clinic
Thrasher Research Fund
Principal Investigator: Dominique Darmaun, MD, PhD Nemours Children's Clinic
Nemours Children's Clinic
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP