Trial · Interventional

CompletedNot applicableResults postedRegistry data

Glutamine and Insulin Sensitivity in Type I Diabetes

NCTNCT01467063Other idIRC# 11-29

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Measures Glucagon, does not give it. It appears in an outcome measure.
Names Glutathione, does not test it. It appears in the conditions.

Overview

Status: Completed
Phase: Not applicable
Enrollment: 13 participants (actual)
Sponsor: Nemours Children's Clinic · Other
Design: Randomized · Triple masking
Countries: 1 country
United States
Start: Oct 2011
Primary completion: Jun 2013
Completion: Jul 2013
First posted: 8 Nov 2011 (estimated)
Last update posted: 14 Jul 2021
Conditions: Type I Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2011201220132014

N/A
Glutamine and Insulin Sensitivity in Type I Diabetes
NCT01467063
Oct 2011 to Jul 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

GlutamineDietary supplement
PlaceboDietary supplement

Arms2

Active comparator
Glutamine
Placebo comparator
Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

Insulin Sensitivity
Time frame · During the Hyperinsulinemic-Euglycemic Clamp, an average of 3 hours
Registry 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).

Secondary outcomes(1)

Glucagon-like Peptide 1 (GLP-1)
Time frame · Post-Infusion

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· During the Hyperinsulinemic-Euglycemic Clamp, an average of 3 hours

Insulin Sensitivity

Group	Value (mL/kg/min per uU/mL)	Spread
Glutamine	0.1	0.02
Placebo	0.07	0.02

Secondary and other outcome results(1)

Secondary outcomeLeast squares mean· Post-Infusion

Glucagon-like Peptide 1 (GLP-1)

Group	Value (pmol/L)	Spread
Glutamine	2.3	0.3
Placebo	1.8	0.1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
GlutamineThirteen subjects were recruited, 12 of 13 completed the study; 2 did not receive isotope infusions but underwent all other procedures and were included in all analyses.	0 / 13	0 / 13	0 / 13
PlaceboThirteen subjects were recruited, 12 of 13 completed the study; 2 did not receive isotope infusions but underwent all other procedures and were included in all analyses.	0 / 13	0 / 13	0 / 13

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

ResultTorres-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. PMID 28063503

Eligibility

Who could join, as posted.

Sex: All
Age: from 13 Years up to 19 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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