Effect of Victoza on Dietary Preferences and Habit in Patients With Type 2 Diabetes (GLP1 et Goût)

University Hospital Center (CHU) Dijon Bourgogne

Status and phase

Terminated

Phase 4

Conditions

Overweight

Type 2 Diabetes

Treatments

Other: Observation alone

Drug: Liraglutide

Study type

Interventional

Funder types

Other

Identifiers

NCT02674893

BRINDISI 2013

Details and patient eligibility

About

This is an open-label comparative study in three parallel groups. It is expected that 90 patients and/or healthy volunteers will participate in this biomedical research.

Distribution in groups

30 patients with type 2 diabetes and an indication for treatment with a GLP1 analogue (group 1)
30 patients with type 2 diabetes (control diabetic subjects) not treated with Incretins (group 2)
30 healthy subjects (non-diabetics) (group 3)

This study will investigate modifications in eating behaviour induced by Liraglutide in patients who start treatment with Victoza® and certain aspects, such as liking (hedonic characteristic of a food), wanting (desire to eat a given food) and salivation in response to the presentation of a food by taking measurements at D0 (before initiation of the treatment with Liraglutide in the group concerned) then at 15 days (except for the controls), 3 months and 9 months (only for controls).

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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....