Clinical trial NCT00108524: A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss
Official title: A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Obesity
Keywords: anti-obesity agents
diet therapy
diet, reducing
obesity
overweight
risk factors
weight loss
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-04-18
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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 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

Primary outcomes:
measure: Change From Baseline in Body Weight at 48 Weeks
timeFrame: baseline and 48 weeks
Secondary outcomes:
measure: Change From Baseline in Risk Factors for Heart Disease (e.g., Lipid Profiles) at 48 Weeks
timeFrame: baseline and 48 weeks
measure: Change From Baseline in Blood Sugar at 48 Weeks
timeFrame: Baseline and 48 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center HSR&D COE
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center HSR&D COE
name: William S. Yancy, MD MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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. doi: 10.1001/archinternmed.2009.492.