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:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT00207233
Eligibility Criteria:
Inclusion Criteria:
* Patient of the Nutrition and Weight Management Center at Boston Medical Center
* Obese ( BMI equal or greater to 30 kg/m2
* Men and women
* Age more than or equal to 18 years
* Type 2 diabetes mellitus controlled by diet or use of Metformin or Impaired fasting glucose (FBS more than or equal to 100 mg/dl)
* Only diet-controlled diabetics or those on Metformin will be considered since all classes of anti-diabetic agents have different effects on appetite and body weight, which may confound the interpretation of study results.
Exclusion Criteria:
* Currently not a patient at the Nutrition and Weight Management Center at Boston Medical Center
* Need for oral anti-diabetic agents (other than Metformin)
* Abnormal thyroid status: hyperthyroidism or hypothyroidism (TSH less than 0.5 or more than 5.0)
* Significant liver disease (bilirubin more than or equal to 2.0 or liver enzyme more than 3 times upper limited of normal range)
* Significant renal disease (creatinine more than or equal to 2.0)
* On the following medications known to affect carbohydrate and lipid metabolism: steroids, Beta adrenergic blockers, diuretics, insulin, and hypolipidemic agents
* Use of prescription or over the counter weight loss medications
* Weight loss of \>5% or more in the last three (3) months
* Anorexia nervosa or bulimia nervosa
* Pregnancy or lactation
* Significant lactose intolerance
* Significant egg allergy
* History of drug or alcohol addiction.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00207233
Study Brief:
Protocol Section:
NCT00207233