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

NCT ID: NCT02674893

Last Updated: 2019-09-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-04
• Study Completion Date: 2016-08-31

Brief Summary

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).

Conditions

Type 2 Diabetes; Overweight

Study Design

• Intervention Model: PARALLEL

Study Groups

type 2 diabetics treated with GLP1 analogue

Group Type: EXPERIMENTAL

Liraglutide

Intervention Type: DRUG

Type 2 diabetics not treated with incretins

Group Type: ACTIVE_COMPARATOR

Observation alone

Intervention Type: OTHER

Healthy subjects

Group Type: OTHER

Observation alone

Intervention Type: OTHER

Interventions

Liraglutide

Intervention Type: DRUG

Observation alone

Intervention Type: OTHER

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….

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de DIJON

Dijon, , France

Countries

France

References

Brindisi MC, Brondel L, Meillon S, Barthet S, Grall S, Fenech C, Lienard F, Schlich P, Astruc K, Mouillot T, Jacquin-Piques A, Leloup C, Verges B, Penicaud L. Proof of concept: Effect of GLP-1 agonist on food hedonic responses and taste sensitivity in poor controlled type 2 diabetic patients. Diabetes Metab Syndr. 2019 Jul-Aug;13(4):2489-2494. doi: 10.1016/j.dsx.2019.06.021. Epub 2019 Jun 29.

Reference Type: DERIVED

PMID: 31405666 (View on PubMed)

Other Identifiers

BRINDISI 2013

Identifier Type: -

Identifier Source: org_study_id