ObesityPhase 3NCT00108459
Low Carbohydrate Diet Compared to Calorie and Fat Restricted Diet in Patients With Obesity and Type II Diabetes
A Phase 3 study testing Low Carbohydrate Diet in people with Obesity and Type 2 Diabetes, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
This study is designed to address the hypothesis that in obese patients with type 2 diabetes mellitus (DM), a low carbohydrate diet not specifically restricted in calories compared to low fat, caloric restricted diet over 24 months will cause 5% greater reduction in body weight in patients with obesity and type 2 DM… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Type 2 Diabetes, Hyperlipidemia
- What is being tested?
- Low Carbohydrate Diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Dec 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects > 18 years of age
- Clinical diagnosis of type 2 diabetes mellitus or on insulin or oral hypoglycemic agents
- Body mass index of > 30 kg/m2
- The subject must we willing and able to monitor their blood glucose with a glucometer at least 2 times per week.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Low Carbohydrate Diet in Obesity and Type 2 DM: RCT
This study is designed to address the hypothesis that in obese patients with type 2 diabetes mellitus (DM), a low carbohydrate diet not specifically restricted in calories compared to low fat, caloric restricted diet over 24 months will cause 5% greater reduction in body weight in patients with obesity and type 2 DM, be safe, and will not have any detrimental effects on serum lipid concentrations.
Read the detailed description
Objectives:
This study is designed to address the hypothesis that in obese patients with type 2 DM, a low carbohydrate diet not specifically restricted in calories compared to low fat, caloric restricted diet over a 24 months period will:
- Primary:
- Cause 5% greater reduction in body weight in patients with obesity and type 2 DM;
- Be safe and will not have any detrimental effects on serum lipid concentrations
- Secondary:
- Lead to a greater reduction in HbA1c and fasting serum glucose and insulin concentration;
- Lead to reduction in body fat content;
- Cause greater reduction in serum triglyceride concentration;
- Cause no significant changes in proteinuria, serum low-density lipoprotein (LDL), high-density lipoprotein (HDL), creatinine and uric acid concentrations
- Exploratory:
Cause favorable changes in adipocytokines (serum leptin, resistin, TNF-α, TNF α- receptors, free fatty acids) and high sensitive C-reactive protein
Research Design:
This will be a single site (Philadelphia VA Medical Center); two arm, parallel, randomized, clinical trial. Obese, male, type 2 diabetic subjects (body mass index [BMI] >30 kg/m2) will be randomized in a 1:1 fashion to dietary instructions for low carbohydrate or low fat diet. Women will be randomized separately (blocks of 4) to ensure equal representation in both dietary groups. Recruitment will be done in 3 phases (for logistical reasons). Subjects will be randomized to one of the two dietary groups. One group will be instructed on a carbohydrate-restricted diet, and the other on a calorie and fat restricted diet as recommended by the National Heart, Lung and Blood Institute (NHLBI). All patients will have blood, urine, and body composition analyses measured at baseline and then at 26, 52, and 104 weeks. Dietary instructions will be given to subjects in groups of 13, and will be provided every week for the first 4 weeks and then every 4 weeks for a total of 30 visits.
Methodology: The setting is the outpatient clinics of the Philadelphia Veterans Affairs Medical Center. Inclusion criteria include: Male or female subjects > 18 years of age; Clinical diagnosis of type 2 diabetes mellitus; Body mass index of > 30 kg/m2 . Approximately 156 male and female veterans from the Philadelphia Veterans Affairs Medical Center will be enrolled in this study.
- Conditions
- Obesity, Type 2 Diabetes, Hyperlipidemia
- Being tested
- Low Carbohydrate Diet
- Keywords
- Obesity, Type 2 Diabetes, Hyperlipidemia, Insulin resistance
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Hyperlipidemias, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Carbohydrate DietBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2005 (estimated)
- Study startSep 2004
- Study completionDec 2007
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 ObesityStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Nayyar Iqbal, Principal investigator, VA Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00108459
- Sponsor's protocol ID
- ENDA-002-03F
- Status last verified
- Jul 2007
- First submitted
- 15 Apr 2005
- Last updated
- 21 Jan 2009
- Results posted
- No
Publications
Iqbal N, Vetter ML, Moore RH, Chittams JL, Dalton-Bakes CV, Dowd M, Williams-Smith C, Cardillo S, Wadden TA. Effects of a low-intensity intervention that prescribed a low-carbohydrate vs. a low-fat diet in obese, diabetic participants. Obesity (Silver Spring). 2010 Sep;18(9):1733-8. doi: 10.1038/oby.2009.460. Epub 2009 Dec 17.
PubMed 20019677
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Low Carbohydrate Diet in Obesity and Type 2 DM: RCT
- ClinicalTrials.gov ID
- NCT00108459
- Acronym / sponsor ID
- ENDA-002-03F
- Conditions
- Obesity, Type 2 Diabetes, Hyperlipidemia
- Keywords
- Obesity, Type 2 Diabetes, Hyperlipidemia, Insulin resistance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Sep 2004
- Study completion
- Dec 2007
- First posted
- 18 Apr 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.
This study is designed to address the hypothesis that in obese patients with type 2 diabetes mellitus (DM), a low carbohydrate diet not specifically restricted in calories compared to low fat, caloric restricted diet over 24 months will cause 5% greater reduction in body weight in patients with obesity and type 2 DM, be safe, and will not have any detrimental effects on serum lipid concentrations.
Detailed description
Objectives:
This study is designed to address the hypothesis that in obese patients with type 2 DM, a low carbohydrate diet not specifically restricted in calories compared to low fat, caloric restricted diet over a 24 months period will:
- Primary:
- Cause 5% greater reduction in body weight in patients with obesity and type 2 DM;
- Be safe and will not have any detrimental effects on serum lipid concentrations
- Secondary:
- Lead to a greater reduction in HbA1c and fasting serum glucose and insulin concentration;
- Lead to reduction in body fat content;
- Cause greater reduction in serum triglyceride concentration;
- Cause no significant changes in proteinuria, serum low-density lipoprotein (LDL), high-density lipoprotein (HDL), creatinine and uric acid concentrations
- Exploratory:
Cause favorable changes in adipocytokines (serum leptin, resistin, TNF-α, TNF α- receptors, free fatty acids) and high sensitive C-reactive protein
Research Design:
This will be a single site (Philadelphia VA Medical Center); two arm, parallel, randomized, clinical trial. Obese, male, type 2 diabetic subjects (body mass index [BMI] >30 kg/m2) will be randomized in a 1:1 fashion to dietary instructions for low carbohydrate or low fat diet. Women will be randomized separately (blocks of 4) to ensure equal representation in both dietary groups. Recruitment will be done in 3 phases (for logistical reasons). Subjects will be randomized to one of the two dietary groups. One group will be instructed on a carbohydrate-restricted diet, and the other on a calorie and fat restricted diet as recommended by the National Heart, Lung and Blood Institute (NHLBI). All patients will have blood, urine, and body composition analyses measured at baseline and then at 26, 52, and 104 weeks. Dietary instructions will be given to subjects in groups of 13, and will be provided every week for the first 4 weeks and then every 4 weeks for a total of 30 visits.
Methodology: The setting is the outpatient clinics of the Philadelphia Veterans Affairs Medical Center. Inclusion criteria include: Male or female subjects > 18 years of age; Clinical diagnosis of type 2 diabetes mellitus; Body mass index of > 30 kg/m2 . Approximately 156 male and female veterans from the Philadelphia Veterans Affairs Medical Center will be enrolled in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects > 18 years of age
- Clinical diagnosis of type 2 diabetes mellitus or on insulin or oral hypoglycemic agents
- Body mass index of > 30 kg/m2
- The subject must we willing and able to monitor their blood glucose with a glucometer at least 2 times per week.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Low Carbohydrate Diet | Behavioural | – |
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 21 Jan 2009.
- Derived from this study: PubMed 20019677Iqbal N, Vetter ML, Moore RH, Chittams JL, Dalton-Bakes CV, Dowd M, Williams-Smith C, Cardillo S, Wadden TA. Effects of a low-intensity intervention that prescribed a low-carbohydrate vs. a low-fat diet in obese, diabetic participants. Obesity (Silver Spring). 2010 Sep;18(9):1733-8. doi: 10.1038/oby.2009.460. Epub 2009 Dec 17.
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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.
Nayyar Iqbal principal investigator
VA Research
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 Low Carbohydrate Diet in people with Obesity and Type 2 Diabetes, run by US Department of Veterans Affairs 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 4 inclusion and 0 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 21 Jan 2009. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00108459, 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 21 Jan 2009.