Type 2 DiabetesPhase 3NCT00737347
Prevention of Weight Gain in Adult Patients With Type 2 Diabetes Treated With Pioglitazone
A Phase 3 study testing Lifestyle modification in people with Type 2 Diabetes and Obesity, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of the study is to investigate the effectiveness of three lifestyle treatment programs varying in level of intensiveness on prevention of pioglitazone-induced weight gain and to measure the composition of the change in body weight. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Obesity
- What is being tested?
- Lifestyle modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Apr 2008
- Phase
- Phase 3
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- type 2 diabetes with BMI 27 or greater, glycated hemoglobin 7% or greater
Who cannot join
- insulin treated
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital Wellness Institute
Chicago, Illinois, 60611
About this study
The purpose of the study is to investigate the effectiveness of three lifestyle treatment programs varying in level of intensiveness on prevention of pioglitazone-induced weight gain and to measure the composition of the change in body weight.
Read the detailed description
The three lifestyle interventions were usual care (1 visit), standard care (4 total visits) and intensive care (10 total visits)
- Conditions
- Type 2 Diabetes, Obesity
- Being tested
- Lifestyle modification
- Keywords
- type 2 diabetes, obesity, weight gain, thiazolidinediones
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle modificationBehavioural
Also called lifestyle behavioral counseling
lifestyle intervention includes meal planning, food preparation, food label reading, dining out, and physical activity counseling
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | usual care. Subjects had one 90 minute visit with registered dietitian |
| 2. | Active comparator | Standard care. Subjects had 4 sessions with registered dietitian Receives: Behavioral: Lifestyle modification |
| 3 | Active comparator | Intensive care. subjects had 10 visits with registered dietitian Receives: Behavioral: Lifestyle modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in body weight
Measured: 24 weeks
Secondary outcomes (1)
change in body composition
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2008 (estimated)
- Study startSep 2003
- Primary completionMar 2007
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Investigators
- Robert F Kushner, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737347
- Sponsor's protocol ID
- 0309-015
- Status last verified
- Aug 2008
- First submitted
- 15 Aug 2008
- Last updated
- 19 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Weight Gain in Adult Patients With Type 2 Diabetes Treated With Pioglitazone
- ClinicalTrials.gov ID
- NCT00737347
- Acronym / sponsor ID
- 0309-015
- Conditions
- Type 2 Diabetes, Obesity
- Keywords
- type 2 diabetes, obesity, weight gain, thiazolidinediones
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- Sep 2003
- Primary completion
- Mar 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 19 Aug 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.
The purpose of the study is to investigate the effectiveness of three lifestyle treatment programs varying in level of intensiveness on prevention of pioglitazone-induced weight gain and to measure the composition of the change in body weight.
Detailed description
The three lifestyle interventions were usual care (1 visit), standard care (4 total visits) and intensive care (10 total visits)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –usual care. Subjects had one 90 minute visit with registered dietitian |
| 2. | Active comparator | Behavioral: Lifestyle modificationStandard care. Subjects had 4 sessions with registered dietitian |
| 3 | Active comparator | Behavioral: Lifestyle modificationIntensive care. subjects had 10 visits with registered dietitian |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- type 2 diabetes with BMI 27 or greater, glycated hemoglobin 7% or greater
Key exclusion criteria (1 listed)
- insulin treated
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 |
|---|---|---|
| Lifestyle modificationAlso: lifestyle behavioral counselinglifestyle intervention includes meal planning, food preparation, food label reading, dining out, and physical activity counseling | Behavioural | 2., 3 |
Primary outcome
change in body weight
Time frame: 24 weeks
1 secondary outcome
change in body composition
Time frame: 24 weeks
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 19 Aug 2008.
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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.
Robert F Kushner, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lifestyle modification in people with Type 2 Diabetes and Obesity, run by Northwestern University 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 19 Aug 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
change in body weight (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2008.