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 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT02674893
Eligibility Criteria:
Inclusion Criteria:
DIABETIC PATIENTS TREATED WITH LIRAGLUTIDE
* persons who have provided written informed consent
* aged \> 18 years
* type 2 diabetes with HbA1C \> 7%
* overweight (BMI \> 27)
* normal renal function (creatinine clearance \> 50ml/min)
* patients to be treated with Liraglutide (patients with type 2 diabetes with HbA1C \> 7.5% and overweight or obesity, whose current treatment is insufficient to control the diabetes).
CONTROL DIABETIC PATIENTS
* persons who have provided written informed consent
* aged \> 18 years
* type 2 diabetes with HbA1C \> 7%
* overweight (BMI \> 27)
* patients for whom treatment with Liraglutide is not indicated
* normal renal function (creatinine clearance \> 50ml/min)
HEALTHY SUBJECTS
* persons who have provided written informed consent
* aged \> 18 years
Exclusion Criteria:
DIABETIC PATIENTS TREATED WITH LIRAGLUTIDE
* type 1 diabetes
* decompensated congestive heart failure
* acute or chronic infection, progressive cancer, liver cirrhosis
* ongoing treatment with antibiotics
* smoking
* chronic alcohol abuse (\>4 glasses a day)
* aversion to the products to be eaten or smelled
* poor understanding of the cognitive tasks requested
* treatment interfering with olfactogustatory performance, such as psychotropic, anti-emetic and anti-ulcer drugs
* persons without national health insurance cover
* persons under guardianship
* hypersensitivity to Liraglutide
* pregnancy, breastfeeding
* history of acute or chronic pancreatitis
* calcitonin level at selection ≥ 50 ng/L
* liver disease, defined by a level of alanine aminotransferase (ALAT) ≥ 2.5 times the upper limit of normal (ULN) for reference values
CONTROL DIABETIC PATIENTS
* type 1 diabetes,
* decompensated congestive heart failure,
* acute or chronic infection, progressive cancer, liver cirrhosis,
* ongoing treatment with antibiotics,
* smoking
* chronic alcohol abuse (\> 4 glasses a day),
* aversion to the products to be eaten or smelled,
* poor understanding of the cognitive tasks requested,
* treatment interfering with olfactogustatory performance, such as psychotropic, anti-emetic and anti-ulcer drugs.
* persons without national health insurance cover
* persons under guardianship
HEALTHY SUBJECTS
* diabetes (type I and II)
* sensory disorders
* decompensated congestive heart failure,
* acute or chronic infection, progressive cancer, liver cirrhosis,
* ongoing treatment with antibiotics,
* smoking
* chronic alcohol abuse (\> 4 glasses a day),
* aversion to the products to be eaten or smelled,
* poor understanding of the cognitive tasks requested,
* treatment interfering with olfactogustatory performance (psychotropic, anti-emetic, anti-ulcer drugs)
* persons without national health insurance cover
* persons under guardianship
* contra-indications to MRI, notably, but not limited to: pace maker, implantable cardiac defibrillators, neurostimulators, cochlear implants, certain implanted automated injection systems (insulin pumps), vascular intracerebral ferromagnetic clips, certain systems to regulate intravascular temperature, myopia requiring the patients to wear spectacle, history of stroke or transient ischemic attack (TIA), metallic foreign body, in particular intraocular or situated near high-risk zones (nervous system, vascular system), claustrophobia….
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02674893
Study Brief:
Protocol Section:
NCT02674893