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Completed

NCT Number: NCT01127997

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

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.

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Key information

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Vincent's hospital

Suwon, Kyounggi-do, 442-723, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. the mechanism of second-meal phenomenon

    Time frame: 3 months

    serum FFA, plasma insulin, C-peptide, incretin concentration will be measured

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 21, 2010
Registry last updated
Aug 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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