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

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ClinicalTrials.gov Identifier: NCT00884091
Recruitment Status : Completed
First Posted : April 20, 2009
Last Update Posted : December 6, 2011
Sponsor:
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital,Taiwan

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.

Condition or disease
Healthy

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.


Study Type : Observational
Actual Enrollment : 21 participants
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
Study Start Date : April 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Glucagon
U.S. FDA Resources

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



Primary Outcome Measures :
  1. the differences in post-challenge GLP-1 responses between the two meal tests [ Time Frame: 8 months ]

Secondary Outcome Measures :
  1. the correlations of incremental GLP-1 response with insulin sensitivity and insulin secretion indices in each of the meal test [ Time Frame: 8 months ]

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.


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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: April 20, 2009    Key Record Dates
Last Update Posted: December 6, 2011
Last Verified: December 2011

Keywords provided by vghtpe user, 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
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins