Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT00564551
Eligibility Criteria:
Inclusion Criteria:
* Overweight and obese (BMI of 27 to 37 kg/m2)
* Impaired glucose tolerance (fasting blood glucose \>5.6 mmol/L) or
* Type 2 diabetes treated with diet and exercise alone (no medications)
* One or more of the following criteria for metabolic syndrome:
1. Hypertriglyceridemia (\> 1.70 mmol/L)
2. Low high-density lipoprotein (HDL) cholesterol (\< 1.04 mmol/L in men and \< 1.30 mmol/L in women)
3. High blood pressure (\> 130/85 mm Hg)
4. High waist circumference ( \> 94 cm in men, \> 80 cm in women)
* Weight stable and no changes in exercise in past 3 months
Exclusion Criteria:
* Type 1 diabetes
* Type 2 diabetes treated with oral hypoglycemic agents or insulin
* HbA1c \> 8%
* myocardial infarction or have undergone a cardiovascular intervention within the past three months
* Subjects taking fibrate or statins who have had a dose change within the 8 weeks prior to randomization
* Liver or pancreas disease
* Major gastrointestinal surgeries
* Pregnant or lactating
* Exhibit alcohol or drug dependence
* Taking drugs influencing appetite
* Have a milk allergy or lactose intolerance
* Following a diet or exercise regime designed for weight loss
* Have a body weight greater than 350 lb (weight limit for DEXA instrument)
* Chronic use of bulk laxatives, antacids or calcium supplements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT00564551
Study Brief:
Protocol Section:
NCT00564551