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 @ 12:05 PM
Ignite Modification Date:
2025-12-24 @ 12:05 PM
NCT ID:
NCT01377961
Eligibility Criteria:
Study group 1( arm 1 ::metabolic syndrome group).
Inclusion criteria:
* Age 18-75 years
* Metabolic Syndrome (IDF criteria)
* Stable dose of medications for \> 90 days
Exclusion criteria:
* Pharmacological therapy for diabetes
* Flood allergies, especially to Whey protein, soy or tomato.
* Pregnancy
Study group 2( Arm 2:: Diabetes mellitus patients group).
Inclusion criteria:
* 18-75 years of age
* Type 2 diabetes (diagnosed with ADA criteria: fasting plasma glucose \> 125 mg/dL)
* Stable dose of medications for \> 90 days
* Patients on diet/exercise, metformin, DD4 inhibitors (sitagliptin and saxagliptin) and /or sulphonylurea for \> 90 days
Exclusion criteria:
* HbA1c above 9.5% or below 7.5% in last 3 months
* TZD therapy for diabetes
* Insulin therapy for diabetes
* Flood allergies, especially to Whey protein, soy or tomato
* Pregnancy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01377961
Study Brief:
Protocol Section:
NCT01377961