Type 2 Diabetes MellitusTwo-for-2NCT00729196
A Trial of Two Diets for Weight and Diabetes Management
A study testing Lifestyle Modification in people with Type 2 Diabetes Mellitus and Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a low-fat or low-glycemic load diet is more effective for controlling weight and blood glucose in persons with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, 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
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Jun 2010
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes Mellitus
- Body mass index (BMI) of 27 to 45 kg/m2 with weight </= 136 kg (300 lbs.
- Capacity to provide written informed consent
- Systolic blood pressure between 90 and 160 mm Hg, inclusive.
- Diastolic blood pressure between 65 and 100 mm Hg, inclusive.
- Resting heart rate between 65 and 90 beats per minute, inclusive.
Who cannot join
- a recent (i.e., within 1 year) myocardial infarction
- unstable angina
- malignant arrhythmias
- history of cerebrovascular, renal, or hepatic disease
- history of seizures
- protein wasting diseases (e.g., Cushing's syndrome)
Show all 13Show fewer
- uncontrolled hypertension (> 160/100 mm Hg)
- type 1 diabetes
- uncontrolled thyroid disease
- pregnancy or lactation
- electrolyte abnormalities
- clinically significant psychosocial impairment (principally, major depression)
- treatment with steroids
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania, Center for Weight and Eating Disorders
Philadelphia, Pennsylvania, 19104-3309
About this study
The purpose of this study is to determine whether a low-fat or low-glycemic load diet is more effective for controlling weight and blood glucose in persons with type 2 diabetes.
Read the detailed description
This research is a randomized controlled trial to compare long-term outcomes behavioral weight loss interventions that include either low-fat or low-glycemic load dietary instruction. Targets for energy intake and expenditure, and behavioral skills taught, are identical across the two diets. Additionally, both treatments include 20 weekly group sessions, followed by 10 every-other-week sessions. Participants are overweight and obese adults with type 2 diabetes. The primary outcomes are changes in weight and glycated hemoglobin. Those randomized to the low-glycemic load diet are expected to achieve greater weight losses and maintain better glycemic control at the end of treatment (i.e., week 40) and after 1 year of no-treatment follow-up (i.e., week 92).
- Conditions
- Type 2 Diabetes Mellitus, Obesity
- Being tested
- Lifestyle Modification
- Keywords
- Obesity, Type 2 Diabetes, Glycemic Load, Weight Loss, Glycated Hemoglobin
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle ModificationBehavioural
Weekly group therapy for 20 weeks, followed by bi-weekly group therapy for 20 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Low-Glycemic Load Diet Receives: Behavioral: Lifestyle Modification |
| 2 | Active comparator | Low-Fat Diet Receives: Behavioral: Lifestyle Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in weight
Measured: 92 weeks
Secondary outcomes (1)
Change in HbA1c
Measured: 92 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2008 (estimated)
- Study startJul 2005
- Primary completionMay 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Pennsylvania
- Investigators
- Anthony N Fabricatore, Ph.D., Principal investigator, University of PennsylvaniaThomas A Wadden, Ph.D., Study director, University of PennsylvaniaVirginia A Stallings, M.D., Study director, Children's Hospital of PhiladelphiaStanley Schwartz, M.D., Study director, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729196
- Sponsor's protocol ID
- K23 DK70777 (completed)
- Other IDs
- K23DK070777
- Acronym
- Two-for-2
- Status last verified
- Jan 2011
- First submitted
- 5 Aug 2008
- Last updated
- 1 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Two Diets for Weight and Diabetes Management
- ClinicalTrials.gov ID
- NCT00729196
- Acronym / sponsor ID
- Two-for-2 / K23 DK70777 (completed)
- Conditions
- Type 2 Diabetes Mellitus, Obesity
- Keywords
- Obesity, Type 2 Diabetes, Glycemic Load, Weight Loss, Glycated Hemoglobin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- University of Pennsylvania
- Study start
- Jul 2005
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 7 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 this study is to determine whether a low-fat or low-glycemic load diet is more effective for controlling weight and blood glucose in persons with type 2 diabetes.
Detailed description
This research is a randomized controlled trial to compare long-term outcomes behavioral weight loss interventions that include either low-fat or low-glycemic load dietary instruction. Targets for energy intake and expenditure, and behavioral skills taught, are identical across the two diets. Additionally, both treatments include 20 weekly group sessions, followed by 10 every-other-week sessions. Participants are overweight and obese adults with type 2 diabetes. The primary outcomes are changes in weight and glycated hemoglobin. Those randomized to the low-glycemic load diet are expected to achieve greater weight losses and maintain better glycemic control at the end of treatment (i.e., week 40) and after 1 year of no-treatment follow-up (i.e., week 92).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Lifestyle ModificationLow-Glycemic Load Diet |
| 2 | Active comparator | Behavioral: Lifestyle ModificationLow-Fat Diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 2 Diabetes Mellitus
- Body mass index (BMI) of 27 to 45 kg/m2 with weight </= 136 kg (300 lbs.
- Capacity to provide written informed consent
- Systolic blood pressure between 90 and 160 mm Hg, inclusive.
- Diastolic blood pressure between 65 and 100 mm Hg, inclusive.
Key exclusion criteria (13 listed)
- a recent (i.e., within 1 year) myocardial infarction
- unstable angina
- malignant arrhythmias
- history of cerebrovascular, renal, or hepatic disease
- history of seizures
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 ModificationWeekly group therapy for 20 weeks, followed by bi-weekly group therapy for 20 weeks | Behavioural | 1, 2 |
Primary outcome
Percent change in weight
Time frame: 92 weeks
1 secondary outcome
Change in HbA1c
Time frame: 92 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 1 Feb 2011.
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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.
Anthony N Fabricatore, Ph.D. principal investigator
University of Pennsylvania
Thomas A Wadden, Ph.D. study director
University of Pennsylvania
Virginia A Stallings, M.D. study director
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Modification in people with Type 2 Diabetes Mellitus and Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 6 inclusion and 13 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 1 Feb 2011. 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.
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?
Percent change in weight (time frame: 92 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 1 Feb 2011.