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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01127997
First Posted: May 21, 2010
Last Update Posted: August 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The Catholic University of Korea
  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:


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)
Groups/Cohorts
study A
post-breakfast meal tolerance test + post-lunch meal tolerance test
study B
fasting + post-lunch meal tolerance test

  Eligibility

Information from the National Library of Medicine

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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
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
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): 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