Type 2 DiabetesNCT00776243
Short-term Effect of Intensive Insulin Therapy on Incretin Secretion
An observational study of Type 2 Diabetes, run by The Catholic University of Korea at 2 sites in South Korea.
Trial summary
In type 2 diabetic patients, abnormality in secretion or action of incretin(GLP-1, GIP) is observed. Although controversy still exists, the secretion of GLP-1 is thought to be reduced by 20-30% while GIP secretion is normal or slightly elevated, in type 2 diabetic patients. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 30 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Oct 2008to Dec 2009
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Subjects with normal glucose tolerance 2. Early diabetic patients with disease duration of less than 5years 3. Uncontrolled diabetic patients
Who may be able to join
- type 2 diabetic patients with disease duration of less than 15years
- age of 20-70 years
- BMI 22-27
- HbA1c 9-13%
- patients willing to receive intensive glucose control
- patients who are able to monitor their glucose level at home
- for normal glucose tolerance group : NGT subjects with same range of age and BMI
- for early diabetes group : patients with diabetic duration of less than 5 years and HbA1c level less than 7.5% for at least last 6 months
Who cannot join
- previous history of insulin treatment
- patients taking alpha-glucosidase inhibitor or thiazolidinedione
- serum creatinine >= 1.5 mg/dL
- hemoglobin < 10 g/dL
- AST/ALT greater than 3 times normal range
- ischemic heart disease, congestive heart failure (NYHA grade >=2)
Show all 10Show fewer
- chronic renal failure, proliferative diabetic retinopathy, CVA
- patients with gastroparesis or taking medications altering gastric motility
- usage of steroid or other agents affecting glucose metabolism
- pregnant or breast-feeding women
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Division of Endocrinology and Metabolism, Kangnam St.Mary's Hospital
Seoul, 137-701
Division of Endocrinology and Metabolism, St.Vincent's Hospital
Suwon, Kyonggi-do, 442-723
About this study
In type 2 diabetic patients, abnormality in secretion or action of incretin(GLP-1, GIP) is observed. Although controversy still exists, the secretion of GLP-1 is thought to be reduced by 20-30% while GIP secretion is normal or slightly elevated, in type 2 diabetic patients. Various parameters such as the duration of diabetes, the amount of meal and their constitution, gastric bypass surgery, and some antidiabetic drugs affect the secretion of incretin. However, the secretion of GLP-1 and GIP in glucotoxic condition and whether they recover after improvement of glycemic status is not known. The investigators aim to study the effect of intensive insulin treatment in uncontrolled diabetic patients.
- Conditions
- Type 2 Diabetes
- Keywords
- incretin, GLP-1, GIP, intensive insulin therapy
- 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 |
|---|---|---|
| wDM | Early diabetes | |
| pDM | Poorly controlled diabetic patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of incretin secretion before and after intensive insulin therapy
Measured: 2 months
Secondary outcomes (2)
Difference in incretin secretion according to the duration of diabetes
Measured: basal
Factors affecting incretin secretion
Measured: basal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2009
- Study completionDec 2009
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
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Investigators
- Kun-Ho Yoon, M.D., Ph.D., Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776243
- Sponsor's protocol ID
- KCMC08MI168
- Other IDs
- VCMC08OT066
- Status last verified
- Oct 2009
- First submitted
- 20 Oct 2008
- Last updated
- 12 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Meier JJ, Nauck MA. Is secretion of glucagon-like peptide-1 reduced in type 2 diabetes mellitus? Nat Clin Pract Endocrinol Metab. 2008 Nov;4(11):606-7. doi: 10.1038/ncpendmet0946. Epub 2008 Aug 26. No abstract available.
PubMed 18725906Vollmer K, Holst JJ, Baller B, Ellrichmann M, Nauck MA, Schmidt WE, Meier JJ. Predictors of incretin concentrations in subjects with normal, impaired, and diabetic glucose tolerance. Diabetes. 2008 Mar;57(3):678-87. doi: 10.2337/db07-1124. Epub 2007 Dec 5.
PubMed 18057091Nauck MA, Baller B, Meier JJ. Gastric inhibitory polypeptide and glucagon-like peptide-1 in the pathogenesis of type 2 diabetes. Diabetes. 2004 Dec;53 Suppl 3:S190-6. doi: 10.2337/diabetes.53.suppl_3.s190.
PubMed 15561910Toft-Nielsen MB, Damholt MB, Madsbad S, Hilsted LM, Hughes TE, Michelsen BK, Holst JJ. Determinants of the impaired secretion of glucagon-like peptide-1 in type 2 diabetic patients. J Clin Endocrinol Metab. 2001 Aug;86(8):3717-23. doi: 10.1210/jcem.86.8.7750.
PubMed 11502801
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effect of Intensive Insulin Therapy on Incretin Secretion
- ClinicalTrials.gov ID
- NCT00776243
- Acronym / sponsor ID
- KCMC08MI168
- Conditions
- Type 2 Diabetes
- Keywords
- incretin, GLP-1, GIP, intensive insulin therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 21 Oct 2008 (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.
In type 2 diabetic patients, abnormality in secretion or action of incretin(GLP-1, GIP) is observed. Although controversy still exists, the secretion of GLP-1 is thought to be reduced by 20-30% while GIP secretion is normal or slightly elevated, in type 2 diabetic patients. Various parameters such as the duration of diabetes, the amount of meal and their constitution, gastric bypass surgery, and some antidiabetic drugs affect the secretion of incretin. However, the secretion of GLP-1 and GIP in glucotoxic condition and whether they recover after improvement of glycemic status is not known. The investigators aim to study the effect of intensive insulin treatment in uncontrolled diabetic patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| wDM | – | –Early diabetes |
| pDM | – | –Poorly controlled diabetic patients |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Subjects with normal glucose tolerance 2. Early diabetic patients with disease duration of less than 5years 3. Uncontrolled diabetic patients
Key inclusion criteria (8 listed)
- type 2 diabetic patients with disease duration of less than 15years
- age of 20-70 years
- BMI 22-27
- HbA1c 9-13%
- patients willing to receive intensive glucose control
Key exclusion criteria (10 listed)
- previous history of insulin treatment
- patients taking alpha-glucosidase inhibitor or thiazolidinedione
- serum creatinine >= 1.5 mg/dL
- hemoglobin < 10 g/dL
- AST/ALT greater than 3 times normal range
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
Difference of incretin secretion before and after intensive insulin therapy
Time frame: 2 months
2 secondary outcomes
Difference in incretin secretion according to the duration of diabetes
Time frame: basal
Factors affecting incretin secretion
Time frame: basal
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 12 May 2010.
- Background: PubMed 18725906Meier JJ, Nauck MA. Is secretion of glucagon-like peptide-1 reduced in type 2 diabetes mellitus? Nat Clin Pract Endocrinol Metab. 2008 Nov;4(11):606-7. doi: 10.1038/ncpendmet0946. Epub 2008 Aug 26. No abstract available.
- Background: PubMed 18057091Vollmer K, Holst JJ, Baller B, Ellrichmann M, Nauck MA, Schmidt WE, Meier JJ. Predictors of incretin concentrations in subjects with normal, impaired, and diabetic glucose tolerance. Diabetes. 2008 Mar;57(3):678-87. doi: 10.2337/db07-1124. Epub 2007 Dec 5.
- Background: PubMed 15561910Nauck MA, Baller B, Meier JJ. Gastric inhibitory polypeptide and glucagon-like peptide-1 in the pathogenesis of type 2 diabetes. Diabetes. 2004 Dec;53 Suppl 3:S190-6. doi: 10.2337/diabetes.53.suppl_3.s190.
- Background: PubMed 11502801Toft-Nielsen MB, Damholt MB, Madsbad S, Hilsted LM, Hughes TE, Michelsen BK, Holst JJ. Determinants of the impaired secretion of glucagon-like peptide-1 in type 2 diabetic patients. J Clin Endocrinol Metab. 2001 Aug;86(8):3717-23. doi: 10.1210/jcem.86.8.7750.
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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.
Kun-Ho Yoon, M.D., Ph.D. principal investigator
The Catholic University of Korea
2 sites 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 2 sites 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 8 inclusion and 10 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 12 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Difference of incretin secretion before and after intensive insulin therapy (time frame: 2 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 NCT00776243, 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 12 May 2010.