Diabetes MellitusNCT00108524

A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss

A study testing Low carbohydrate ketogenic diet, Orlistat and Low-fat diet in people with Diabetes Mellitus and Obesity, run by US Department of Veterans Affairs at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study compares two types of diet interventions: a low carbohydrate ketogenic diet (Atkins) and a low-fat diet combined with a medication (Orlistat). Read more about this study

Who is it for?: Ages 18 to 69 yearsHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus, Obesity
What is being tested?: Low carbohydrate ketogenic diet, Orlistat and Low-fat diet
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 146 participants
Where: 1 siteUnited States
Study dates: Jul 2004to Dec 2007
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 69 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participants must have a VA medical center primary care provider;
Failed first line diet and exercise recommendations;
In stable health by screening physical and lab tests;
Agrees to make regular visits per study protocol;
Has access to telephone;
Body mass index (BMI) > or = 27 with obesity-related illness OR BMI > or = 30 with no risk factors;

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No contraindications to Orlistat;
Not pregnant or breast-feeding;
No serious mental health illness such as dementia or schizophrenia;
No use of a weight loss therapy in the month prior to screening.

Who cannot join

No VAMC primary care provider
Unable to attend regular study visits
No access to telephone
BMI < 27
Contraindications to Orlistat
Pregnancy, breast feeding or planning to become pregnant
Unstable mental health illness
Use of a weight loss therapy in the month prior to screening

Trial locations and contacts

1 site in 1 country.

United States1 site

Durham VA Medical Center HSR&D COE
Durham, North Carolina, 27705

Other trials in United States

About this study

This study compares two types of diet interventions: a low carbohydrate ketogenic diet (Atkins) and a low-fat diet combined with a medication (Orlistat).

Read the detailed description

Overweight and obesity are increasingly prevalent in the veteran population as well as the general public. For patients with obesity-associated illnesses, there are few effective treatment options available after failed attempts at diet and exercise, even though weight loss has been shown to alleviate these conditions. The purpose of this study is to compare the tolerability, safety, and efficacy of a low-carbohydrate ketogenic diet (Atkins) with a combination of a low-fat diet and Orlistat. The outcomes examined over a 48 week duration will include body weight, risk factors for heart disease (e.g., lipid profiles), and blood sugar. This is a randomized, parallel-intervention trial. Subjects (n=150) will be recruited from the Durham VAMC Ambulatory Care Clinics. All patients receive one of the two intensive weight loss interventions.

Conditions: Diabetes Mellitus, Obesity
Being tested: Low carbohydrate ketogenic diet, Orlistat, Low-fat diet
Keywords: anti-obesity agents, diet therapy, diet, reducing, obesity, overweight, risk factors, weight loss
Medical subject headings: Diabetes Mellitus, Obesity, Overweight, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Low carbohydrate ketogenic dietBehavioural
A low-carb diet limits carbohydrates - such as grains, starchy vegetables and fruit - and emphasizes dietary protein and fat.
OrlistatDrug
Also called Xenical
In addition to the low fat diet, Orlistat is taken 3 times daily.
Low-fat dietBehavioural
Participants receive counseling on a low fat diet over 48 weeks aimed at reducing fat and calorie intake

Study groups in NCT00108524
Study group	Role	What they receive
Low Carbohydrate Ketogenic Diet	Experimental	Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake. Receives: Behavioral: Low carbohydrate ketogenic diet
Low-Fat Diet plus Orlistat	Active comparator	Participants receive counseling on a low fat diet over 48 weeks aimed at reducing fat and calorie intake, and additionally receive Orlistat taken 3 times daily. Receives: Drug: Orlistat; Behavioral: Low-fat diet

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Body Weight at 48 Weeks
Body weight was measured using the same calibrated scale (Tanita Corp, Arlington Heights, Illinois) at each visit at the same time of day, with the participant wearing light clothing and no shoes.
Measured: baseline and 48 weeks

Secondary outcomes (2)

Change From Baseline in Risk Factors for Heart Disease (e.g., Lipid Profiles) at 48 Weeks
Measured change in low-density lipoprotein cholesterol, or LDL-C, from baseline to 48 weeks.
Measured: baseline and 48 weeks
Change From Baseline in Blood Sugar at 48 Weeks
Measured change in Fasting glucose, mg/dL, from baseline to 48 weeks.
Measured: Baseline and 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2004Dec 2007

First posted18 Apr 2005 (estimated)
Study startJul 2004
Primary completionDec 2007
Study completionDec 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 146 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00108524
Sponsor's protocol ID: CLIN-005-03F
Status last verified: Mar 2014
First submitted: 15 Apr 2005
Last updated: 17 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Mayer SB, Jeffreys AS, Olsen MK, McDuffie JR, Feinglos MN, Yancy WS Jr. Two diets with different haemoglobin A1c and antiglycaemic medication effects despite similar weight loss in type 2 diabetes. Diabetes Obes Metab. 2014 Jan;16(1):90-3. doi: 10.1111/dom.12191. Epub 2013 Aug 29.
PubMed 23911112
Yancy WS Jr, Almirall D, Maciejewski ML, Kolotkin RL, McDuffie JR, Westman EC. Effects of two weight-loss diets on health-related quality of life. Qual Life Res. 2009 Apr;18(3):281-9. doi: 10.1007/s11136-009-9444-8. Epub 2009 Feb 11.
PubMed 19212822
Yancy WS Jr, Westman EC, McDuffie JR, Grambow SC, Jeffreys AS, Bolton J, Chalecki A, Oddone EZ. A randomized trial of a low-carbohydrate diet vs orlistat plus a low-fat diet for weight loss. Arch Intern Med. 2010 Jan 25;170(2):136-45. doi: 10.1001/archinternmed.2009.492.
PubMed 20101008

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss
ClinicalTrials.gov ID: NCT00108524
Acronym / sponsor ID: CLIN-005-03F
Conditions: Diabetes Mellitus, Obesity
Keywords: anti-obesity agents, diet therapy, diet, reducing, obesity, overweight, risk factors, weight loss
Study type: Interventional
Recruitment status: Completed
Enrolment: 146 participants (actual)
Lead sponsor: US Department of Veterans AffairsUS federal agency
Study start: Jul 2004
Primary completion: Dec 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 18 Apr 2005 (estimated)
Results: Posted 12 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study compares two types of diet interventions: a low carbohydrate ketogenic diet (Atkins) and a low-fat diet combined with a medication (Orlistat).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Low Carbohydrate Ketogenic Diet	Experimental	Behavioral: Low carbohydrate ketogenic dietParticipants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
Low-Fat Diet plus Orlistat	Active comparator	Drug: Orlistat, Behavioral: Low-fat dietParticipants receive counseling on a low fat diet over 48 weeks aimed at reducing fat and calorie intake, and additionally receive Orlistat taken 3 times daily.

Who may qualify

Ages: 18 to 69 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Participants must have a VA medical center primary care provider;
Failed first line diet and exercise recommendations;
In stable health by screening physical and lab tests;
Agrees to make regular visits per study protocol;
Has access to telephone;

Key exclusion criteria (8 listed)

No VAMC primary care provider
Unable to attend regular study visits
No access to telephone
BMI < 27
Contraindications to Orlistat

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 ketogenic dietA low-carb diet limits carbohydrates - such as grains, starchy vegetables and fruit - and emphasizes dietary protein and fat.	Behavioural	Low Carbohydrate Ketogenic Diet
OrlistatAlso: XenicalIn addition to the low fat diet, Orlistat is taken 3 times daily.	Drug	Low-Fat Diet plus Orlistat
Low-fat dietParticipants receive counseling on a low fat diet over 48 weeks aimed at reducing fat and calorie intake	Behavioural	Low-Fat Diet plus Orlistat

Primary outcome

Change From Baseline in Body Weight at 48 Weeks
Time frame: baseline and 48 weeks
Body weight was measured using the same calibrated scale (Tanita Corp, Arlington Heights, Illinois) at each visit at the same time of day, with the participant wearing light clothing and no shoes.

2 secondary outcomes

Change From Baseline in Risk Factors for Heart Disease (e.g., Lipid Profiles) at 48 Weeks
Time frame: baseline and 48 weeks
Change From Baseline in Blood Sugar at 48 Weeks
Time frame: Baseline and 48 weeks

Results and safety

Results posted to the registry on 12 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low Carbohydrate Ketogenic Diet	81	52
Low-Fat Diet Plus Orlistat	79	61

Primary outcome: Change From Baseline in Body Weight at 48 Weeks

Time frame: baseline and 48 weeks. Mean (95% Confidence Interval). Unit: percentage of weight loss

Measure	Arm 1 n = 72	Arm 2 n = 74
Value	-9.5 (-14.8 to -7.9)	-8.5 (-11.0 to -6.1)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 48 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1	1 of 72 (1.4%)	49 of 72 (68.1%)	Not reported
Arm 2	2 of 74 (2.7%)	30 of 74 (40.5%)	Not reported

Limitations and caveats (from the sponsor): We provided orlistat at no cost. This could have increased dietary adherence, attendance, and/or retention compared with the LCKD and may lead to different results than what might be seen in patients who must pay for orlistat.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23911112Mayer SB, Jeffreys AS, Olsen MK, McDuffie JR, Feinglos MN, Yancy WS Jr. Two diets with different haemoglobin A1c and antiglycaemic medication effects despite similar weight loss in type 2 diabetes. Diabetes Obes Metab. 2014 Jan;16(1):90-3. doi: 10.1111/dom.12191. Epub 2013 Aug 29.
Results publication: PubMed 19212822Yancy WS Jr, Almirall D, Maciejewski ML, Kolotkin RL, McDuffie JR, Westman EC. Effects of two weight-loss diets on health-related quality of life. Qual Life Res. 2009 Apr;18(3):281-9. doi: 10.1007/s11136-009-9444-8. Epub 2009 Feb 11.
Results publication: PubMed 20101008Yancy WS Jr, Westman EC, McDuffie JR, Grambow SC, Jeffreys AS, Bolton J, Chalecki A, Oddone EZ. A randomized trial of a low-carbohydrate diet vs orlistat plus a low-fat diet for weight loss. Arch Intern Med. 2010 Jan 25;170(2):136-45. doi: 10.1001/archinternmed.2009.492.

Related trials for Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Recruiting
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Recruiting
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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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.

William S. Yancy, MD MHS principal investigator

Durham VA Medical Center HSR&D COE

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Low carbohydrate ketogenic diet, Orlistat and Low-fat diet in people with Diabetes Mellitus and Obesity, 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 10 inclusion and 8 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 17 Apr 2014. 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?

Yes. Results are posted in the registry (first posted 12 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 From Baseline in Body Weight at 48 Weeks (time frame: baseline and 48 weeks). 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 NCT00108524, which also lists 3 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 17 Apr 2014.