Expired Study
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Durham, North Carolina 27705


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).


Study summary:

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.


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. Exclusion Criteria: - 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


Study is Available At:


Original ID:

CLIN-005-03F


NCT ID:

NCT00108524


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

69 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Department of Veterans Affairs


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

150


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:William S. Yancy, MD MHS
Principal Investigator
Durham VA Medical Center HSR&D COE

Study Dates

Start Date:July 2004
Completion Date:December 2007
Completion Type:Actual
Primary Completion Date:December 2007
Primary Completion Type:Actual
Verification Date:September 2013
Last Changed Date:September 12, 2013
First Received Date:April 15, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Blood sugar
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Risk factors for heart disease (e.g., lipid profiles)
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Body weight
Time Frame:48 weeks
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Low carbohydrate ketogenic diet
Arm Name:Arm 1
Intervention Type:Drug
Name:Orlistat plus a low-fat diet
Arm Name:Arm 2

Study Arms

Study Arm Type:Active Comparator
Arm Name:Arm 2
Description:Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.
Study Arm Type:Experimental
Arm Name:Arm 1
Description:Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:Department of Veterans Affairs

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Mayer SB, Jeffreys AS, Olsen MK, McDuffie JR, Feinglos MN, Yancy WS. Two Diets with Different Hemoglobin A(1c) and Antiglycemic Medication Effects Despite Similar Weight Loss in Type 2 Diabetes. Diabetes Obes Metab. 2013 Aug 2. doi: 10.1111/dom.12191. [Epub ahead of print]
PMID:23911112
Reference Type:Results Reference
Citation: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.
PMID:20101008
Reference Type:Results Reference
Citation: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.
PMID:19212822

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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