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 @ 2:02 PM
Ignite Modification Date:
2025-12-24 @ 2:02 PM
NCT ID:
NCT01241695
Eligibility Criteria:
Inclusion Criteria:
* diagnosis of type 2 diabetes according to the WHO diagnostic criteria for more than 6 months: Fasting plasma glucose (FPG) ≥ 126 mg/dl (7.0 mmol/l) or 2-h plasma glucose ≥ 200 mg/dl (11.1 mmol/l) during an OGTT (oral glucose tolerance test);
* HbA1c between 6.5-8.5 % (confirmed in the previous 3 months),
* capable of using oral nutritional supplementation,
* on stable and controlled anti-diabetic regime for at least 1 months,
* use of metformin and/or sulphonylureas as oral anti-diabetic medication,
* in need of nutritional support because of ≥5% involuntary weight loss in the last 3 months, ≥10% involuntary weight loss in the last 6 months, inadequate nutritional intake causing failure to meet nutritional requirements or at risk of developing malnutrition
Exclusion Criteria:
* diabetes type 1,
* participation in a clinical trial with an investigational product or regular use of disease-specific oral nutritional supplements within 4 weeks prior to study start
* patients requiring a fibre free diet,
* enteral tube feed or parenteral nutrition,
* concomitant therapy with systemic glucocorticoids, insulins or anti-diabetic medication other than metformin and sulphonylureas,
* known or suspected intolerance or allergy to any component of the investigational product(s),
* any acute gastrointestinal disease within 2 weeks prior to study entry,
* gastrectomy, gastroparesis or other gastric emptying abnormalities,
* acute sever heart failure (NYHA class 4), liver insufficiency / failure (male: ALAT \> 150 U/l; female: ALAT \> 120 U/l) or renal failure requiring dialysis,
* cancer cachexia,
* galactosaemia, fructosaemia,
* suspicion of drug abuse, abuse of/addiction to alcohol,
* pregnant or breast feeding women, or fertile women refusing to use contraceptives,
* patients with untreated major psychiatric disorder,
* known HIV positive (safety reasons),
* patient unable to co-operate adequately
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT01241695
Study Brief:
Protocol Section:
NCT01241695