Diabetes Mellitus, Obesity
Conditions
Keywords
anti-obesity agents, diet therapy, diet, reducing, obesity, overweight, risk factors, weight loss
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.
Interventions
BEHAVIORALLow carbohydrate ketogenic diet
A low-carb diet limits carbohydrates - such as grains, starchy vegetables and fruit - and emphasizes dietary protein and fat.
DRUGOrlistat
In addition to the low fat diet, Orlistat is taken 3 times daily.
BEHAVIORALLow-fat diet
Participants receive counseling on a low fat diet over 48 weeks aimed at reducing fat and calorie intake
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Body Weight at 48 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Risk Factors for Heart Disease (e.g., Lipid Profiles) at 48 Weeks | baseline and 48 weeks | Measured change in low-density lipoprotein cholesterol, or LDL-C, from baseline to 48 weeks. |
| Change From Baseline in Blood Sugar at 48 Weeks | Baseline and 48 weeks | Measured change in Fasting glucose, mg/dL, from baseline to 48 weeks. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from outpatient clinics affiliated with the Department of Veterans Affairs Medical Center in Durham, North Carolina, between April 2005 and October 2006.
Pre-assignment details
18-70yo,BMI 27-30+obesity-related disease or BMI\>30 regardless of comorbidity. Excluded:weight loss in \<30 days;pregnant,breastfeeding,DM-1;unstable heart disease or psych illness,dementia,substance abuse;HTN \>160/100; creatinine\>1.5men,\>1.3women; HemA1c\>11%; triglyceride\>600; LDL-C\>190. Not considered enrolled if not told group assignment (n=14).
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
Low carbohydrate ketogenic diet: Participants were instructed to restrict carbohydrate intake initially to less than 20 g/d using pocket guides and handouts. Participants could eat unlimited meat and eggs, 112 g of hard cheese, 0.48 L of low-carbohydrate vegetables (eg, leafy greens), and 0.24 L of moderate-carbohydrate vegetables (eg, broccoli, asparagus) daily; calorie intake was not restricted. As participants approached their goal weight or if cravings threatened their adherence to the diet, they were advised to add approximately 5 g of carbohydrates to their daily intake each week until weight was maintained or cravings diminished. | 72 |
| Arm 2 Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.
Orlistat plus a low-fat diet: Participants were instructed to restrict intake of total fat (\<30% of daily energy), saturated fat (\<10% of daily energy), cholesterol (\<300 mg daily), and calories using pocket guides, handouts, and individualized goals. Recommended calorie intake was 500 to 1000 kcal below a participant's calculated weight maintenance intake. In addition, a 30-day supply of orlistat (120 mg before meals 3 times a day) was provided monthly. | 74 |
| Total | 146 |
Baseline characteristics
| Characteristic | Arm 2 | Arm 1 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 74 Participants | 72 Participants | 146 Participants |
| Age, Continuous | 52.0 years STANDARD_DEVIATION 9.2 | 52.9 years STANDARD_DEVIATION 10.2 | 52 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 74 participants | 72 participants | 146 participants |
| Sex: Female, Male Female | 21 Participants | 20 Participants | 41 Participants |
| Sex: Female, Male Male | 53 Participants | 52 Participants | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 49 / 72 | 30 / 74 |
| serious Total, serious adverse events | 1 / 72 | 2 / 74 |
Outcome results
Primary
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.
Time frame: baseline and 48 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1 | Change From Baseline in Body Weight at 48 Weeks | -9.5 percentage of weight loss |
| Arm 2 | Change From Baseline in Body Weight at 48 Weeks | -8.5 percentage of weight loss |
Secondary
Change From Baseline in Blood Sugar at 48 Weeks
Measured change in Fasting glucose, mg/dL, from baseline to 48 weeks.
Time frame: Baseline and 48 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1 | Change From Baseline in Blood Sugar at 48 Weeks | -9.74 mg/dL |
| Arm 2 | Change From Baseline in Blood Sugar at 48 Weeks | -3.54 mg/dL |
Secondary
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.
Time frame: baseline and 48 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1 | Change From Baseline in Risk Factors for Heart Disease (e.g., Lipid Profiles) at 48 Weeks | -1.91 mg/dL |
| Arm 2 | Change From Baseline in Risk Factors for Heart Disease (e.g., Lipid Profiles) at 48 Weeks | -8.29 mg/dL |