Type 2 Diabetes MellitusPhase 4NCT00522470
Effects of Rosiglitazone on Serum Ghrelin and Peptide YY Levels
A Phase 4 study testing rosiglitazone in people with Type 2 Diabetes Mellitus and Obesity, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
We aimed to evaluate the effects of rosiglitazone on serum ghrelin and peptide yy levels in diabetic women. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Type 2 Diabetes Mellitus, Obesity
- What is being tested?
- rosiglitazone
- How many people
- Not given
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Start not givento not given
- Phase
- Phase 4
- 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 45 to 65 years
- Women only
- Adult, Older adult
Who may be able to join
- newly diagnosed, drug naive women with type 2 diabetes
Who cannot join
- presence of severe cardiovascular disease (eg, New York Heart Association class III or IV congestive heart failure or a history of myocardial infarction or stroke)
- presence of thyroid, pituitary, nutritional, hepatic, renal, or neoplastic disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University Hospital Department of Endocrinology
Ankara, Bahçelievler, 06490
About this study
Official title: Effects of Rosiglitazone on Serum Ghrelin and Peptide YY Levels in Diabetic Women
We aimed to evaluate the effects of rosiglitazone on serum ghrelin and peptide yy levels in diabetic women.
- Conditions
- Type 2 Diabetes Mellitus, Obesity
- Being tested
- rosiglitazone
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rosiglitazoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Investigators
- Zehra Berberoglu, MD, Principal investigator, Baskent University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522470
- Sponsor's protocol ID
- KA 06/299
- Status last verified
- May 2008
- First submitted
- 27 Aug 2007
- Last updated
- 9 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Berberoglu Z, Yazici AC, Bayraktar N, Demirag NG. Rosiglitazone decreases fasting plasma peptide YY3-36 in type 2 diabetic women: a possible role in weight gain? Acta Diabetol. 2012 Dec;49 Suppl 1:S115-22. doi: 10.1007/s00592-011-0352-3. Epub 2011 Nov 19.
PubMed 22101910
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rosiglitazone on Serum Ghrelin and Peptide YY Levels in Diabetic Women
- ClinicalTrials.gov ID
- NCT00522470
- Acronym / sponsor ID
- KA 06/299
- Conditions
- Type 2 Diabetes Mellitus, Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- First posted
- 29 Aug 2007 (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.
We aimed to evaluate the effects of rosiglitazone on serum ghrelin and peptide yy levels in diabetic women.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- newly diagnosed, drug naive women with type 2 diabetes
Key exclusion criteria (2 listed)
- presence of severe cardiovascular disease (eg, New York Heart Association class III or IV congestive heart failure or a history of myocardial infarction or stroke)
- presence of thyroid, pituitary, nutritional, hepatic, renal, or neoplastic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rosiglitazone | Drug | – |
Primary outcome
Not reported in the source record.
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 9 May 2008.
- Derived from this study: PubMed 22101910Berberoglu Z, Yazici AC, Bayraktar N, Demirag NG. Rosiglitazone decreases fasting plasma peptide YY3-36 in type 2 diabetic women: a possible role in weight gain? Acta Diabetol. 2012 Dec;49 Suppl 1:S115-22. doi: 10.1007/s00592-011-0352-3. Epub 2011 Nov 19.
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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.
Zehra Berberoglu, MD principal investigator
Baskent University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rosiglitazone in people with Type 2 Diabetes Mellitus and Obesity, run by Baskent University at 1 site in Turkey (Türkiye).
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 1 inclusion and 2 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 9 May 2008. 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00522470, which also lists 1 linked publication.
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 9 May 2008.