Diabetes MellitusPhase 4TAKE IINCT00219440
A Portion-controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS
A Phase 4 study testing Actos plus standard diet, Actos plus structured diet and Metformin plus standard diet in people with Diabetes Mellitus, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
We hypothesized that a portion controlled diet would prevent the weight gain associated with the use of a peroxisome profliferator-activated receptor-gamma (PPAR-g). This is a 4 months randomized clinical trial in type 2 diabetics who are treated with pioglitazone and a standard diet, pioglitazone and a… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Actos plus standard diet, Actos plus structured diet and Metformin plus standard diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Dec 2006
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women age 35 to 75 who have type 2 diabetes mellitus
Who cannot join
- Individuals with co-existing other diseases
Trial locations and contacts
1 site in 1 country.
About this study
We hypothesized that a portion controlled diet would prevent the weight gain associated with the use of a peroxisome profliferator-activated receptor-gamma (PPAR-g). This is a 4 months randomized clinical trial in type 2 diabetics who are treated with pioglitazone and a standard diet, pioglitazone and a portion-controlled diet and metformin with a standard diet.
Read the detailed description
A total of 60 male and female type 2 diabetic subjects will be recruited and randomized into 1 of 3 treatment groups for the 4 months long trial
- ACTOS plus a standard diet
- ACTOS plus a portion-controlled diet
- Metformin plus a standard diet. The end-point of the trial is the change in body fat content from baseline to the end of the trial
- Conditions
- Diabetes Mellitus
- Being tested
- Actos plus standard diet, Actos plus structured diet, Metformin plus standard diet
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actos plus standard dietOther
Actos plus standard diet
Actos plus structured dietOther
Actos plus structured diet
Metformin plus standard dietOther
Metformin plus standard diet
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | ACTOS plus standard diet Receives: Other: Actos plus standard diet |
| B | Experimental | Actos plus structured diet Receives: Other: Actos plus structured diet |
| C | Experimental | Metformin plus standard diet Receives: Other: Metformin plus standard diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose
Measured: 4 months
Secondary outcomes (2)
Change in lipids
Measured: 4 months
blood pressure
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startFeb 2003
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George A. Bray, Pennington Biomedical Research Center
- Investigators
- George A Bray, MD, Principal investigator, Pennington Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219440
- Sponsor's protocol ID
- PBRC 24005
- Acronym
- TAKE II
- Status last verified
- Jan 2016
- First submitted
- 14 Sep 2005
- Last updated
- 25 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Martin CK, Gupta AK, Smith SR, Greenway FL, Han H, Bray GA. Effect of pioglitazone on energy intake and ghrelin in diabetic patients. Diabetes Care. 2010 Apr;33(4):742-4. doi: 10.2337/dc09-1600. Epub 2010 Jan 12.
PubMed 20067964Gupta AK, Smith SR, Greenway FL, Bray GA. Pioglitazone treatment in type 2 diabetes mellitus when combined with portion control diet modifies the metabolic syndrome. Diabetes Obes Metab. 2009 Apr;11(4):330-7. doi: 10.1111/j.1463-1326.2008.00965.x.
PubMed 19267711
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Portion-controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS
- ClinicalTrials.gov ID
- NCT00219440
- Acronym / sponsor ID
- TAKE II / PBRC 24005
- Conditions
- Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Feb 2003
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 22 Sep 2005 (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 hypothesized that a portion controlled diet would prevent the weight gain associated with the use of a peroxisome profliferator-activated receptor-gamma (PPAR-g). This is a 4 months randomized clinical trial in type 2 diabetics who are treated with pioglitazone and a standard diet, pioglitazone and a portion-controlled diet and metformin with a standard diet.
Detailed description
A total of 60 male and female type 2 diabetic subjects will be recruited and randomized into 1 of 3 treatment groups for the 4 months long trial
- ACTOS plus a standard diet
- ACTOS plus a portion-controlled diet
- Metformin plus a standard diet. The end-point of the trial is the change in body fat content from baseline to the end of the trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: Actos plus standard dietACTOS plus standard diet |
| B | Experimental | Other: Actos plus structured dietActos plus structured diet |
| C | Experimental | Other: Metformin plus standard dietMetformin plus standard diet |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women age 35 to 75 who have type 2 diabetes mellitus
Key exclusion criteria (1 listed)
- Individuals with co-existing other diseases
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 |
|---|---|---|
| Actos plus standard dietActos plus standard diet | Other | A |
| Actos plus structured dietActos plus structured diet | Other | B |
| Metformin plus standard dietMetformin plus standard diet | Other | C |
Primary outcome
glucose
Time frame: 4 months
2 secondary outcomes
Change in lipids
Time frame: 4 months
blood pressure
Time frame: 4 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 25 Jan 2016.
- Derived from this study: PubMed 20067964Martin CK, Gupta AK, Smith SR, Greenway FL, Han H, Bray GA. Effect of pioglitazone on energy intake and ghrelin in diabetic patients. Diabetes Care. 2010 Apr;33(4):742-4. doi: 10.2337/dc09-1600. Epub 2010 Jan 12.
- Derived from this study: PubMed 19267711Gupta AK, Smith SR, Greenway FL, Bray GA. Pioglitazone treatment in type 2 diabetes mellitus when combined with portion control diet modifies the metabolic syndrome. Diabetes Obes Metab. 2009 Apr;11(4):330-7. doi: 10.1111/j.1463-1326.2008.00965.x.
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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.
George A Bray, MD principal investigator
Pennington Center
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 Actos plus standard diet, Actos plus structured diet and Metformin plus standard diet in people with Diabetes Mellitus, run by Pennington Biomedical Research Center at 1 site in United States.
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 1 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 25 Jan 2016. 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 United States. 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.
What does the primary outcome measure?
glucose (time frame: 4 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 NCT00219440, which also lists 2 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 25 Jan 2016.