Protein, Amino Acids & Insulin & Glucagon Secretion in Humans

Minneapolis Veterans Affairs Health Care System (VAHCS)

Status: Suspended

Conditions: Type 2 Diabetes; Metabolic Syndrome

Treatments: Other: water, glucose with or without amino acid

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01471509

676

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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300 participants in 4 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

240 ml water

Treatment:

Other: water, glucose with or without amino acid

glucose

Active Comparator group

Description:

50 g glucose

Treatment:

Other: water, glucose with or without amino acid

Amino acid

Active Comparator group

Description:

1 mmol amino acid/kg lean body mass

Treatment:

Other: water, glucose with or without amino acid

amino acid plus glucose

Active Comparator group

Description:

50 g glucose plus 1 mmol amino acid/kg lean body mass

Treatment:

Other: water, glucose with or without amino acid