Current partner codePEPTIDESDE
NCT02674893·Phase 4·INTERVENTIONAL

Effect of Victoza on Dietary Preferences and Habit in Patients With Type 2 Diabetes

Status

Terminated

Phase

Phase 4

Enrollment

48

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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).

Interventions

Treatment arms and agents.

DRUG

Liraglutide

OTHER

Observation alone

Timeline

From registration to results.

  1. First posted

    Feb 5, 2016

  2. Study start

    Feb 4, 2014

  3. Primary completion

    Aug 31, 2016

  4. Study completion

    Aug 31, 2016

  5. Results posted

    Not reported

  6. Registry updated

    Feb 9, 2026

Outcomes

What the study measures.

Primary outcomes

Modifications in wanting

Time frame · Up to 3 months

Secondary outcomes

Modifications in gustatory performance

Time frame · Until 3 months

Modifications in liking

Time frame · Until 3 months

Modifications in salivation following the presentation of foods

Time frame · Until 3 months

Modifications in optimal preferences for sweet and fatty tastes

Time frame · Until 3 months

Anthropometric modifications

Time frame · Until 3 months

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
Yes

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….

Study locations

1 registered sites.

France. Showing up to 24 locations stored in the fast local snapshot.

CHU de DIJON

Dijon, France

Related trials

More studies on Liraglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.