Weight Loss and Abdominal Fat Responses to Different Diet Compositions

Status unconfirmed · Not applicable

Conditions studied: Obesity, Insulin Resistance, Metabolic Syndrome

In brief

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.

Key facts

Study ID

NCT01034046

Run by

University of Nevada, Las Vegas

People needed

100

Starts

2009-04-01

Expected to finish

2011-06-01

Last updated by the study team

2010-04-30

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Center for Nutrition and Metabolism at the University of Nevada School of Medicine, Reno — Reno, Nevada, United States

Full record on ClinicalTrials.gov

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