Dataset Information

Glycemic effects and safety of L-Glutamine supplementation with or without sitagliptin in type 2 diabetes patients-a randomized study.

ABSTRACT:

Background and aims

L-glutamine is an efficacious glucagon-like peptide (GLP)-1 secretagogue in vitro. When administered with a meal, glutamine increases GLP-1 and insulin excursions and reduces postprandial glycaemia in type 2 diabetes patients. The aim of the study was to assess the efficacy and safety of daily glutamine supplementation with or without the dipeptidyl peptidase (DPP)-4 inhibitor sitagliptin in well-controlled type 2 diabetes patients.

Methods

Type 2 diabetes patients treated with metformin (n?=?13, 9 men) with baseline glycated hemoglobin (HbA1c) 7.1±0.3% (54±4 mmol/mol) received glutamine (15 g bd)+ sitagliptin (100 mg/d) or glutamine (15 g bd) + placebo for 4 weeks in a randomized crossover study.

Results

HbA1c (P?=?0.007) and fructosamine (P?=?0.02) decreased modestly, without significant time-treatment interactions (both P?=?0.4). Blood urea increased (P<0.001) without a significant time-treatment interaction (P?=?0.8), but creatinine and estimated glomerular filtration rate (eGFR) were unchanged (P?0.5). Red blood cells, hemoglobin, hematocrit, and albumin modestly decreased (P?0.02), without significant time-treatment interactions (P?0.4). Body weight and plasma electrolytes remained unchanged (P?0.2).

Conclusions

Daily oral supplementation of glutamine with or without sitagliptin for 4 weeks decreased glycaemia in well-controlled type 2 diabetes patients, but was also associated with mild plasma volume expansion.

Trial registration

ClincalTrials.gov NCT00673894.

SUBMITTER: Samocha-Bonet D

PROVIDER: S-EPMC4239068 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Publications

Glycemic effects and safety of L-Glutamine supplementation with or without sitagliptin in type 2 diabetes patients-a randomized study.

Samocha-Bonet Dorit D Chisholm Donald J DJ Gribble Fiona M FM Coster Adelle C F AC Carpenter Kevin H KH Jones Graham R D GR Holst Jens J JJ Greenfield Jerry R JR

PloS one 20141120 11

<h4>Background and aims</h4>L-glutamine is an efficacious glucagon-like peptide (GLP)-1 secretagogue in vitro. When administered with a meal, glutamine increases GLP-1 and insulin excursions and reduces postprandial glycaemia in type 2 diabetes patients. The aim of the study was to assess the efficacy and safety of daily glutamine supplementation with or without the dipeptidyl peptidase (DPP)-4 inhibitor sitagliptin in well-controlled type 2 diabetes patients.<h4>Methods</h4>Type 2 diabetes pati ...[more]

PMID: 25412338

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Project description:BackgroundSalsalate, a nonacetylated prodrug of salicylate, has been shown to decrease blood glucose concentration in small studies.ObjectiveTo compare the efficacy and safety of salsalate at different doses in patients with type 2 diabetes.DesignParallel randomized trial with computer-generated randomization and centralized allocation. Patients and investigators, including those assessing outcomes and performing analyses, were masked to group assignment. (ClinicalTrials.gov registration number: NCT00392678)Setting3 private practices and 14 universities in the United States.PatientsPersons aged 18 to 75 years with fasting plasma glucose concentrations of 12.5 mmol/L or less (< or = 225 mg/dL) and hemoglobin A1c (HbA1c) levels of 7.0% to 9.5% treated by diet, exercise, and oral medication at stable doses for at least 8 weeks.InterventionAfter a 4-week, single-masked run-in period, patients were randomly assigned to receive placebo or salsalate in dosages of 3.0, 3.5, or 4.0 g/d for 14 weeks (27 patients each) in addition to their current therapy.MeasurementsChange in HbA1c was the primary outcome. Adverse effects and changes in measures of coronary risk and renal function were secondary outcomes.ResultsHigher proportions of patients in the 3 salsalate treatment groups experienced decreases in HbA1c levels of 0.5% or more from baseline (P = 0.009). Mean HbA1c changes were -0.36% (P = 0.02) at 3.0 g/d, -0.34% (P = 0.02) at 3.5 g/d, and -0.49% (P = 0.001) at 4.0 g/d compared with placebo. Other markers of glycemic control also improved in the 3 salsalate groups, as did circulating triglyceride and adiponectin concentrations. Mild hypoglycemia was more common with salsalate; documented events occurred only in patients taking sulfonylureas. Urine albumin concentrations increased in all salsalate groups compared with placebo. The drug was otherwise well tolerated.LimitationThe number of patients studied and the trial duration were insufficient to warrant recommending the use of salsalate for type 2 diabetes at this time.ConclusionSalsalate lowers HbA1c levels and improves other markers of glycemic control in patients with type 2 diabetes and may therefore provide a new avenue for treatment. Renal and cardiac safety of the drug require further evaluation.Primary funding sourceNational Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health.

Dataset Information

Glycemic effects and safety of L-Glutamine supplementation with or without sitagliptin in type 2 diabetes patients-a randomized study.

Background and aims

Methods

Results

Conclusions

Trial registration

Publications

Glycemic effects and safety of L-Glutamine supplementation with or without sitagliptin in type 2 diabetes patients-a randomized study.

Similar Datasets

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