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 @ 4:28 PM
Ignite Modification Date:
2025-12-24 @ 4:28 PM
NCT ID:
NCT01423266
Eligibility Criteria:
Inclusion Criteria:
* obese (BMI \> 27 kg/m2);
* history of type 2 DM or documented impaired fasting glucose (IFG) according to fasting plasma glucose levels of 100-125 mg/dl or meeting 3 out of 4 criteria or Metabolic Syndrome ( as defined by the International Diabetes Federation 2011
* evaluation of HF and optimization of medical therapy; and
* ischemic or idiopathic HF etiology.
Exclusion Criteria:
* age ≤18 years old;
* history of clinically significant illness including acute myocardial infarction or sustained ventricular arrhythmia in the prior 3 months or current liver, respiratory, and/or gastrointestinal disease and malignancy;
* pregnancy or lactation;
* serum creatinine level \> 1.5 mg/dl;\*
* currently participating in a supervised weight loss program;
* physician refusal to permit patient participation in the study; and
* weight loss of \>6% in the last 6 months
* gout or history of gout
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01423266
Study Brief:
Protocol Section:
NCT01423266