An interventional study of Glutamine and Placebo in Type I Diabetes Mellitus, sponsored by Nemours Children's Clinic. Completed at 1 site in United States. Open to participants aged 13 Years to 19 Years. Per ClinicalTrials.gov, last updated 2021-07-14.
Sponsored by Nemours Children's Clinic · Not applicable, Interventional, and Treatment
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 13 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Nemours Children's Clinic is the lead sponsor of 127 studies on the registry; 27 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Exclusion Criteria:
Dietary Supplement: Glutamine
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 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.
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.
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).
Time frame: During the Hyperinsulinemic-Euglycemic Clamp, an average of 3 hours
Glucagon-like Peptide 1 (GLP-1)
Time frame: Post-Infusion
| Milestone | Glutamine, Then Placebo | Placebo, Then Glutamine |
|---|---|---|
| Started | 6 | 7 |
| Completed | 5 | 7 |
| Not completed | 1 | 0 |
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).
| mL/kg/min per uU/mL | Glutamine | Placebo |
|---|---|---|
| Insulin Sensitivity | 0.1 ± 0.02 | 0.07 ± 0.02 |
| pmol/L | Glutamine | Placebo |
|---|---|---|
| Glucagon-like Peptide 1 (GLP-1) | 2.3 ± 0.3 | 1.8 ± 0.1 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Glutamine | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Placebo | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 16 ± 2 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 5 |
| Male | 8 |
| Region of Enrollment(participants) | All Participants |
|---|---|
| United States | 13 |
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Nemours Children's Clinic