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

This study has been completed.
Information provided by:
The Catholic University of Korea Identifier:
First received: May 20, 2010
Last updated: August 20, 2010
Last verified: May 2010
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.

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

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 ]
    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 ]
    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)
study A
post-breakfast meal tolerance test + post-lunch meal tolerance test
study B
fasting + post-lunch meal tolerance test


Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
type 2 diabetic patients

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
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Please refer to this study by its identifier: NCT01127997

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