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

NCT01127997 | Completed

• 1 other identifier: VC10EISI0007
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• the mechanism of second-meal phenomenon

  3 months

Study Arms (2)

study A

post-breakfast meal tolerance test + post-lunch meal tolerance test

study B

fasting + post-lunch meal tolerance test

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

type 2 diabetic patients

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Catholic University of Korea: lead

Study Sites (1)

St. Vincent's hospital

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

Location

Related Publications (4)

• 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.

  PMID: 19161346 BACKGROUND

• 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.

  PMID: 19531643 BACKGROUND

• 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.

  PMID: 19366973 RESULT

• Lee SH, Tura A, Mari A, Ko SH, Kwon HS, Song KH, Yoon KH, Lee KW, Ahn YB. Potentiation of the early-phase insulin response by a prior meal contributes to the second-meal phenomenon in type 2 diabetes. Am J Physiol Endocrinol Metab. 2011 Nov;301(5):E984-90. doi: 10.1152/ajpendo.00244.2011. Epub 2011 Aug 9.

  PMID: 21828339 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma, serum

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 20, 2010
• First Posted: May 21, 2010
• Study Start: March 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 23, 2010

Record last verified: 2010-05

Locations

KR (1)