Type 2 DiabetesNCT01127997
The Effect and Mechanisms of the Second-meal Phenomenon in Type 2 Diabetic Patients
An observational study of Type 2 Diabetes, run by The Catholic University of Korea at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2010to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: type 2 diabetic patients
Who may be able to join
- age 35-70
- HbA1c 6-8%
- DM duration less than 5 yrs
Who cannot join
- 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)
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- ischemic heart disease, congestive heart failure
- severe diabetic complication (CRF, CVA, PDR, gastroparesis)
- infectious disease
- malignancy
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect and Mechanisms of the Second-meal Phenomenon in Type 2 Diabetic
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
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study A | post-breakfast meal tolerance test + post-lunch meal tolerance test | |
| study B | fasting + post-lunch meal tolerance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months
Secondary outcomes (1)
the mechanism of second-meal phenomenon
serum FFA, plasma insulin, C-peptide, incretin concentration will be measured
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startMar 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127997
- Sponsor's protocol ID
- VC10EISI0007
- Status last verified
- May 2010
- First submitted
- 20 May 2010
- Last updated
- 23 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19161346Bonuccelli 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.
PubMed 19531643Jovanovic 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.
PubMed 19366973Lee 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.
PubMed 21828339
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect and Mechanisms of the Second-meal Phenomenon in Type 2 Diabetic
- ClinicalTrials.gov ID
- NCT01127997
- Acronym / sponsor ID
- VC10EISI0007
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 21 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study A | – | –post-breakfast meal tolerance test + post-lunch meal tolerance test |
| study B | – | –fasting + post-lunch meal tolerance test |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- type 2 diabetic patients
Key inclusion criteria (3 listed)
- age 35-70
- HbA1c 6-8%
- DM duration less than 5 yrs
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
the mechanism of second-meal phenomenon
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2010.
- Background: PubMed 19161346Jovanovic 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.
- Background: PubMed 19531643Bonuccelli 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.
- Results publication: PubMed 19366973Jovanovic 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.
- Derived from this study: PubMed 21828339Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve of plasma glucose after meal (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01127997, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2010.