A Pilot Study to Evaluate the Glucagon-Like Peptide 1 Response to the Challenge of Mixed Meals in Chinese Subjects (IC-1-V1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital,Taiwan
ClinicalTrials.gov Identifier:
NCT00884091
First received: April 16, 2009
Last updated: December 5, 2011
Last verified: December 2011
  Purpose

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.


Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Pilot Study to Evaluate the Glucagon-Like Peptide 1 Response to the Challenge of Mixed Meals in Chinese Subjects

Resource links provided by NLM:


Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • the differences in post-challenge GLP-1 responses between the two meal tests [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the correlations of incremental GLP-1 response with insulin sensitivity and insulin secretion indices in each of the meal test [ Time Frame: 8 months ] [ Designated as safety issue: No ]

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.


Enrollment: 21
Study Start Date: April 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy Adults
  1. Chinese in origin
  2. Healthy
  3. No medication at least two weeks before the study

Detailed Description:

Glucagon-like peptide 1 (GLP-1) is a 30-amino acid peptide produced in the intestinal epithelial endocrine L-cells. It stimulates insulin and suppresses glucagons secretion, inhibits gastric emptying, and reduces appetite and food intake. In the fasting state, the plasma concentrations of GLP-1 are very low. Levels of circulating GLP-1 rise rapidly after food intake. The GLP-1 meal response depends on ingested nutrients. Carbohydrates are strong stimuli of GLP-1 release. Protein stimulates GLP-1 release, even more than carbohydrates. GLP-1 concentrations also increase after intake of fat, although the elevation is delayed compared to the stimulation of carbohydrates. Dietary fibers may also modify the postprandial GLP-1 response. Therefore, it is essential for us to characterize nutrient compositions of test meals for further studies of meal response of GLP-1.

Other sampling conditions of the meal tests are also needed to be taking care of. GLP-1 is rapidly degraded by the enzyme dipeptidyl peptidase IV (DPP-4). During the meal tests, it is important adding enzyme inhibitors into sampling tubes to avoid hormone degradation. Lugari et al. collected blood samples into tubes containing EDTA and aprotinin during a meal test. They could obtain samples from the same tube for both glucagons and GLP-1 assays. Other study groups reported that samples for GLP-1 needed to be collected into Vacutainer tubes prepared with EDTA and DPP-4 inhibitor for preventing degradation of GLP-1. Another aim of the present study is to compare the differences in GLP-1 concentrations in samples collected by EDTA tubes containing aprotinin or a DPP-4 inhibitor during the meal tests.

Racial differences in GLP-1 levels during oral glucose challenge have been demonstrated recently that severely obese African Americans exhibited lower GLP-1 concentrations than Caucasians. It is worthwhile to examine the meal response of GLP-1 across ethnicities. The current study proposes to observe the GLP-1 response during standardized meal tests in a group of Chinese subjects.

The purpose of the study is to standardize a meal test to facilitate future studies of the postprandial 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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Invited normal healthy volunteers from a research clinic

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884091

Locations
Taiwan
Section of Endocrinology and Metabolism, Department of Medicine, Taipei Veterans General Hospital
Taipei, Taiwan, 112
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
Principal Investigator: Chii-Min Hwu, MD Taipei Veterans eneral Hospital
  More Information

No publications provided

Responsible Party: vghtpe user, Attending physician, Taipei Veterans General Hospital,Taiwan
ClinicalTrials.gov Identifier: NCT00884091     History of Changes
Other Study ID Numbers: 98-01-48A
Study First Received: April 16, 2009
Last Updated: December 5, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Veterans General Hospital, Taiwan:
Chinese
Glucagon-like peptide 1
Glucagon
Insulin
Mixed meals
Healthy Adults

Additional relevant MeSH terms:
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins

ClinicalTrials.gov processed this record on September 22, 2014