NCT01599338

Brief Summary

Besides their potential action in the treatment of type 2 diabetes mellitus (T2DM), GLP-1 analogues decrease satiety and food intake leading to a significant weight loss in patients. However, little is known about their effects on food hedonic sensations and taste perception. The aim of this study is to investigate the impact of Liraglutide on the liking and wanting components of the food reward system, taste sensitivity and sensory specific satiety in type 2 diabetes mellitus (T2DM) patients. According to the review of literature in animal models, it is expected that Liraglutide will modify food preference and gustative perception in humans. Thirty T2DM patients will be studied before and after 3 months of treatment with Liraglutide (1.2 mg/day). Same tests will be carried out on two consecutive days before and after the treatment administration. Olfactory liking, recalled liking and wanting for several food items will be assessed. Sensory specific satiety will be measured as well as detection thresholds for salty, sweet and bitter tastes. Subjects will also answer questionnaires on hunger, pleasure in eating, and food intake.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2011

Shorter than P25 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2012

Completed
Last Updated

June 1, 2012

Status Verified

May 1, 2012

Enrollment Period

Same day

First QC Date

May 14, 2012

Last Update Submit

May 31, 2012

Conditions

Type 2 Diabetes MellitusOverweight

Keywords

LiraglutideGLP-1 analogueFood preferenceGustative perceptionLikingwantingT2DMbody mass compositionleptinghrelin

Outcome Measures

Primary Outcomes (4)

  • Change in liking and wanting for protein, lipid and glucid foods

    3 months

  • Change in sensory specific satiety for protein, lipid and glucid foods

    3 months

  • Change in gustative detection thresholds for sweet, bitter and salty tastes

    3 months

  • Change in appetite, desire to eat, pleasure in eating

    3 months

Secondary Outcomes (2)

  • Change in body mass composition (Dual Energy XRay Absorptiometry)

    3 months

  • Change in plasma ghrelin, leptin, and HbA1c levels

    3 months

Study Arms (1)

Liraglutide

EXPERIMENTAL

Single Arm study. T2DM patients are studied before and after 3 months of Liraglutide treatment (1.2 mg/day).

Drug: Liraglutide

Interventions

LiraglutideDRUG

3 months of treatment by Liraglutide (self-administration). The initial dose was 0.6 mg/day subcutaneously during five days, then uptitrated to a daily dose of 1.2 mg during three months.

Also known as: Novonordisk (Puteaux, France)
Liraglutide

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetic patients
  • with glycemic unbalance despite anti-diabetic treatments and
  • overweight (BMI \> 25 kg/m²)

You may not qualify if:

  • Impaired renal function (creatinine clearance \< 50 ml/min),
  • Pregnancy,
  • Congestive heart failure,
  • Acute and chronic infection,
  • Evolutive cancer,
  • Cirrhosis,
  • Ongoing antibiotic treatment,
  • Smoking (more than 5 cig/day),
  • Alcohol consumption (more than 20 g/day),
  • Aversion for the foods eaten or smelt during the study,
  • Impaired comprehension for cognitive tasks,
  • Treatments known to interfere with olfactory and gustative performances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon

Dijon, Bourgogne-Franche-Comté, 21000, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2OverweightFood Preferences

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Marie-Claude Brindisi, MD

    CHU Dijon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 14, 2012

First Posted

May 16, 2012

Study Start

January 1, 2011

Primary Completion

January 1, 2011

Study Completion

September 1, 2011

Last Updated

June 1, 2012

Record last verified: 2012-05

Locations

FR(1)