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The Effect and Mechanisms of the Second-meal Phenomenon in Type 2 Diabetic Patients

This study has been completed.
Sponsor:
Information provided by:
The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01127997
First received: May 20, 2010
Last updated: August 20, 2010
Last verified: May 2010
History of Changes
  Purpose

Second-meal phenomenon denotes the effect of a prior meal in decreasing the rise in blood glucose after a subsequent meal. This phenomenon occurs in normal subjects while it is not clear whether it is also observed in type 2 diabetic patients. This study aims to define whether the second-meal phenomenon occurs in type 2 diabetic patients. We will also seek for the mechanism.


Condition
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Effect and Mechanisms of the Second-meal Phenomenon in Type 2 Diabetic

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • Area under the curve of plasma glucose after meal [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Compare the post-lunch AUC of glucose between two meal tolerance tests(one after having breakfast, one after not having breakfast)


Secondary Outcome Measures:
  • the mechanism of second-meal phenomenon [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    serum FFA, plasma insulin, C-peptide, incretin concentration will be measured


Biospecimen Retention:   Samples Without DNA

plasma, serum


Estimated Enrollment: 12
Study Start Date: March 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
study A
post-breakfast meal tolerance test + post-lunch meal tolerance test
study B
fasting + post-lunch meal tolerance test

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

type 2 diabetic patients

Criteria

Inclusion Criteria:

  • age 35-70
  • HbA1c 6-8%
  • DM duration less than 5 yrs

Exclusion Criteria:

  • type 1 DM, secondary DM, gestational DM
  • patients using insulin, TZDs
  • patients using corticosteroid, herb medication or other medications affecting glucose tolerance
  • renal dysfunction (Cr > 1.5mg/dL)
  • hepatic dysfunction (LFT > x 3UNL)
  • anemia (Hg < 10g/dL)
  • ischemic heart disease, congestive heart failure
  • severe diabetic complication (CRF, CVA, PDR, gastroparesis)
  • infectious disease
  • malignancy
  • pregnant women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01127997

Locations
Korea, Republic of
St. Vincent's hospital
Suwon, Kyounggi-do, Korea, Republic of, 442-723
Sponsors and Collaborators
The Catholic University of Korea
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Seung-Hwan Lee, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01127997     History of Changes
Other Study ID Numbers: VC10EISI0007
Study First Received: May 20, 2010
Last Updated: August 20, 2010
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013