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 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT03289494
Eligibility Criteria:
Inclusion Criteria:
* Patient able to understand the study information and providing written consents for his/her participation to the study
* Male or female
* Patient undergoing medical examination during the selection visit
* Patient aged between 18 and 75 years old (bounds included)
* T2D volunteer with:
* HbA1c between 6,5% and 8,5%
* Bi-therapy associating metformin and sitagliptin at stable dose for at least 1 month
* T2D volunteer without insulin therapy or GLP-1 analogues
* Patient with BMI ranging between 22 and 37 kg/m2 (bounds included)
* Patient with stable body weight over the past three months (+/- 5 % of body weight)
* Patient accepting to change its diet for two weeks
* Patient not suffering from intolerance or allergy
* Patient regularly consuming products proposed in the study
* Patient regularly consuming 3 main meals per day
* Sedentary behavior or stable regular physical activity during the study
* Patient not presenting any disease during the medical examination / interview which could interfere with the results of the study according to the investigator
* Patient covered by health assurance
Exclusion Criteria:
* General criteria:
* Patient under legal protection measure
* Patient deprived of liberty by a court or an administrative decision
* Patient currently participating in another study or being in the exclusion period of another study
* Volunteer that exceed the financial compensation allowed per year for participating in research programs
* Biological criteria:
* Gamma-GT \> 2.5 times above the norm (\>160 UI/L)
* ASAT \> 2.5 times above the norm (\>85 UI/L)
* ALAT \> 2.5 times above the norm (\>137.5 UI/L)
* Triglycerides \> 4 g/L
* LDL-cholesterol \> 1.90 g/L
* CRP \> 15 mg/L
* Hemoglobin \< 120 mg/dL
* Other biological abnormality with clinical significant relevance according to the investigator
* Therapeutic and medical criteria:
* Patient with type 1 diabetes
* T2D treatment other than metformin and sitagliptin
* Patient with past bariatric surgery
* Patient with medical history of endocrine diseases who may interfere with glucose metabolism according to the investigator (such as thyroid dysfunction, acromegaly, hypercorticism…)
* Uncontrolled high blood pressure defined by Systolic blood pressure \> 150 mmHg or Diastolic blood pressure \> 100 mmHg
* Evidence of any other unstable or untreated clinically significant immunological, neoplasic, endocrine, haematological, gastrointestinal, hepatic, neurological or psychiatric abnormalities or medical disease according to the investigator
* Pregnant women or willing to become pregnant or lactating women
* Women of childbearing age without an efficient contraceptive method according to the investigator
* Patient under a restrictive diet or willing to lose weight
* Patient with eating disorders (e.g. anorexia nervosa and bulimia) according to the investigator
* Patient without stable dietary habits or with specific diet (vegetarian, vegan,…) according to the investigator
* Patient who smokes
* Patient regularly consuming more than 20 g/day of alcohol. Consumption of more than 3 alcoholic beverages per day is recognized as excessive. An alcoholic beverage is: 30 mL of spirituous, 120 mL of wine or 330 mL of beer
* Patient regularly consuming recreational drugs
* Patient consuming in the two previous months regularly corticoids, anorectics, adrenergic drugs, beta-blocking drugs, antiplatelet agent (like aspirin) or other drugs or supplement that should impact glucose metabolism (other than metformin or DPP4 inhibitor) in the investigator's opinion
* Adhesive plaster skin allergy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03289494
Study Brief:
Protocol Section:
NCT03289494