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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01127997
• Other study ID #: VC10EISI0007
• Status: Completed
• Phase: N/A
• First received: May 20, 2010
• Last updated: August 20, 2010
• Start date: March 2010
• Est. completion date: August 2010

Study information

• Verified date: May 2010
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Type 2 Diabetes

Locations

Country	Name	City	State
Korea, Republic of	St. Vincent's hospital	Suwon	Kyounggi-do

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Bonuccelli S, Muscelli E, Gastaldelli A, Barsotti E, Astiarraga BD, Holst JJ, Mari A, Ferrannini E. Improved tolerance to sequential glucose loading (Staub-Traugott effect): size and mechanisms. Am J Physiol Endocrinol Metab. 2009 Aug;297(2):E532-7. doi: 10.1152/ajpendo.00127.2009. Epub 2009 Jun 16. — View Citation

Jovanovic A, Gerrard J, Taylor R. The second-meal phenomenon in type 2 diabetes. Diabetes Care. 2009 Jul;32(7):1199-201. doi: 10.2337/dc08-2196. Epub 2009 Apr 14. — View Citation

Jovanovic A, Leverton E, Solanky B, Ravikumar B, Snaar JE, Morris PG, Taylor R. The second-meal phenomenon is associated with enhanced muscle glycogen storage in humans. Clin Sci (Lond). 2009 Jul 2;117(3):119-27. doi: 10.1042/CS20080542. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve of plasma glucose after meal	Compare the post-lunch AUC of glucose between two meal tolerance tests(one after having breakfast, one after not having breakfast)	3 months	No
Secondary	the mechanism of second-meal phenomenon	serum FFA, plasma insulin, C-peptide, incretin concentration will be measured	3 months	No