A Pilot Study to Evaluate the Glucagon-Like Peptide 1 Response to the Challenge of Mixed Meals in Chinese Subjects

NCT00884091 | Completed

• 1 other identifier: 98-01-48A
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to standardize a meal test to facilitate future studies of the postprandial glucagons-like peptide 1 (GLP-1) response in Chinese subjects. Eighteen healthy Chinese subjects, aged between 20-65 years old, without history of diabetes, will be recruited for the study. Each subject will receive two mixed meal tests for postprandial GLP-1 excursion at random order: 60 % carbohydrate (CHO)/20 % fat vs. 50 % CHO/30 % fat. The postprandial glucose, insulin, glucagon and other related hormones responses will also be measured. Through the study, we hope to build up a platform for the study of the postprandial GLP-1 response and insulin secretion.

Conditions

Healthy

Keywords

Chinese; Glucagon-like peptide 1; Glucagon; Insulin; Mixed meals; Healthy Adults

Outcome Measures

Primary Outcomes (1)

• the differences in post-challenge GLP-1 responses between the two meal tests

  8 months

Secondary Outcomes (1)

• the correlations of incremental GLP-1 response with insulin sensitivity and insulin secretion indices in each of the meal test

  8 months

Study Arms (1)

Healthy Adults

1. Chinese in origin 2. Healthy 3. No medication at least two weeks before the study

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Invited normal healthy volunteers from a research clinic

You may qualify if:

• Men or women aged 20 \~ 65 years old.
• Willing to participate by signing an informed consent.
• Willing to undergo two standardized mixed meal test at two separate visits

You may not qualify if:

• Patients of known history of type 2 diabetes.
• History of major renal, liver, heart, blood and neurological disease.
• History of alcoholism or drug abuse.
• Women who are pregnant.
• Current or concomitant illness that would interfere with the subject's ability to perform the study or that would confound the study results, judged by the investigation physicians.
• Any concomitant medication within 2 weeks of the study.
• Difficult venous access

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Section of Endocrinology and Metabolism, Department of Medicine, Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples retained, with no potential for DNA extraction from any retained samples. The retained samples will be destroyed after the results published.

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Chii-Min Hwu, MD

  Taipei Veterans eneral Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: April 16, 2009
• First Posted: April 20, 2009
• Study Start: April 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: December 6, 2011

Record last verified: 2011-12

Locations

TW (1)