Weight Loss and Abdominal Fat Responses to Different Diet Compositions

Nevada System of Higher Education (NSHE) logo

Nevada System of Higher Education (NSHE)

Status

Unknown

Conditions

Insulin Resistance
Obesity
Metabolic Syndrome

Treatments

Other: Low Carbohydrate Diet
Other: Low Fat Diet

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01034046
B08/09-031

Details and patient eligibility

About

The purpose of this study is to assess the effectiveness of two different reduced calorie diets that have different combinations of carbohydrate, fat, and protein content in 2 groups of study participants: insulin sensitive participants and insulin resistant participants. The hypothesis of the study is that people with high and low levels of insulin resistance may respond differently to different diet compositions in a real-world environment using meals that are commonly available.

Enrollment

100 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Females between 18 and 65 years of age.
  • BMI 30-40 kg/m2
  • Stable weight within 10 lb (+/-) for last 2 months

Exclusion criteria

  • Pregnant or lactating.
  • Must not currently be part of a structured weight loss program
  • Taking a medication for diabetes (such as insulin, metformin, glyburide, glipizide, Byetta, pioglitazone, or rosiglitazone) or a medication such as systemic glucocorticoids that are known to affect blood sugar or blood insulin.
  • Beck Depression Inventory (BDI Score >19 and/or positively endorses the suicide question on the BDI-II)
  • Taking any chronic medication that has not had a stable dose for 1 month or longer.
  • Diabetes mellitus defined as a fasting glucose ≥ 126 mg/dL on screening.
  • Taking medications or dietary supplements that cause weight gain or weight loss (eg. antipsychotics (Seroquel, Zyprexa, and Risperdal) and/or anorectics).
  • Clinically significant laboratory abnormalities at the opinion of the investigators.
  • History of Bariatric Surgery

A history of:

  • Type 2 diabetes, type 1 diabetes, or diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. Cushing's syndrome and acromegaly.
  • Liver disease, such as cirrhosis, or chronic active hepatitis B or C.
  • Use of investigational drugs within 30 days of visit 1
  • A pacemaker.
  • Hospitalization for depression in the past 6 months, history of moderate to severe major depression.
  • Any other condition that in the investigators' or sponsor's opinion could interfere with the results of the trial.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups

Insulin Sensitive Study Participants
Active Comparator group
Description:
Insulin sensitive subjects stratified using fasting insulin levels.
Treatment:
Other: Low Fat Diet
Other: Low Carbohydrate Diet
Insulin Resistant Study Subjects
Active Comparator group
Description:
Insulin resistant subjects stratified using fasting insulin levels.
Treatment:
Other: Low Fat Diet
Other: Low Carbohydrate Diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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