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

Sponsor:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00108524

Purpose

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

Condition	Intervention
Obesity Diabetes Mellitus	Behavioral: Low carbohydrate ketogenic diet Drug: Orlistat plus a low-fat diet

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Obesity Weight Control

Drug Information available for: Orlistat

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Body weight
Risk factors for heart disease (e.g., lipid profiles)
Blood sugar

Estimated Enrollment:	150
Study Start Date:	July 2004
Estimated Study Completion Date:	April 2008

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.

Eligibility

Ages Eligible for Study:	18 Years to 69 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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;
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108524

Locations

United States, North Carolina
Durham VA Medical Center
Durham, North Carolina, United States, 27705

Sponsors and Collaborators

Department of Veterans Affairs

More Information

No publications provided by Department of Veterans Affairs

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00108524 History of Changes
Other Study ID Numbers:	CLIN-005-03F
Study First Received:	April 15, 2005
Last Updated:	January 20, 2009
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

obesity
weight loss
diet, reducing
anti-obesity agents

diet therapy
risk factors
overweight

Additional relevant MeSH terms:

Diabetes Mellitus
Obesity
Weight Loss
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight

Signs and Symptoms
Body Weight Changes
Orlistat
Anti-Obesity Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 13, 2012