Protein, Amino Acids & Insulin & Glucagon Secretion in Humans

Study Overview
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Brief Summary
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The purpose of this study is to determine the effect of various foods and/or food substances such as fats or proteins on the blood glucose and insulin concentrations in people with and without type 2 diabetes.

Detailed Description
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Various foods or food substances are given as a test meal. The metabolic response is determined at various times after the administration of the meal (e.g. blood glucose, and other hormones and metabolites).

Official Title
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The Effect of Ingestion of Foods on the Plasma Glucose and Insulin Response in Subjects With Type 2 Diabetes: Protein, Amino Acids & Insulin & Glucagon Secretion in Humans

Conditions
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Type 2 Diabetes, Metabolic Syndrome

Intervention / Treatment
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* Other: water, glucose with or without amino acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with or without type 2 diabetes C-Peptide > 1.5 ng/ml Able to come to the Minneapolis VA Medical Center on several occasions over 2-4 weeks Exclusion Criteria: Body mass index > 40 hematologic abnormalities liver disease kidney disease congestive heart failure life threatening malignancies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>240 ml water | Other: water, glucose with or without amino acid<br>* 240 ml water, 50 g glucose ± 1 mmol amino acid/kg lean body mass<br>* Other names: foods or food constituents;|
| Active Comparator: glucose<br>50 g glucose | Other: water, glucose with or without amino acid<br>* 240 ml water, 50 g glucose ± 1 mmol amino acid/kg lean body mass<br>* Other names: foods or food constituents;|
| Active Comparator: Amino acid<br>1 mmol amino acid/kg lean body mass | Other: water, glucose with or without amino acid<br>* 240 ml water, 50 g glucose ± 1 mmol amino acid/kg lean body mass<br>* Other names: foods or food constituents;|
| Active Comparator: amino acid plus glucose<br>50 g glucose plus 1 mmol amino acid/kg lean body mass | Other: water, glucose with or without amino acid<br>* 240 ml water, 50 g glucose ± 1 mmol amino acid/kg lean body mass<br>* Other names: foods or food constituents;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood glucose concentration | Test substances will be given at 0800 hr and blood drawn at several time points up to 5 hours after the meal. | several time points after ingestion of test substance | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum insulin concentration | Test substances will be given at 0800 hr and blood drawn at several time points up to 5 hours after the meal. | Several time points after ingestion of test substance | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glycemic Index, LoBAG Diet, Insulin, Glucagon