Type 2 Diabetes MellitusNCT01599338
Impact of Liraglutide on Sensory Perception, Sensory Specific Satiety, Liking and Wanting in Type 2 Diabetic Patients
A study testing Liraglutide in people with Type 2 Diabetes Mellitus and Overweight, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Overweight
- What is being tested?
- Liraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetic patients
- with glycemic unbalance despite anti-diabetic treatments and
- overweight (BMI > 25 kg/m²)
Who cannot join
- Impaired renal function (creatinine clearance < 50 ml/min),
- Pregnancy,
- Congestive heart failure,
- Acute and chronic infection,
- Evolutive cancer,
- Cirrhosis,
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence du Victoza (Liraglutide,Analogue GLP-1) Sur Les Performances Gustatives, le Rassasiement Sensoriel spécifique, le Liking et le Wanting Chez Les Patients diabétiques de Type 2.
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.
- Conditions
- Type 2 Diabetes Mellitus, Overweight
- Being tested
- Liraglutide
- Keywords
- Liraglutide, GLP-1 analogue, Food preference, Gustative perception, Liking, wanting, T2DM, body mass composition, leptin, ghrelin
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Also called Novonordisk (Puteaux, France)
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.
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | Experimental | Single Arm study. T2DM patients are studied before and after 3 months of Liraglutide treatment (1.2 mg/day). Receives: Drug: Liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in liking and wanting for protein, lipid and glucid foods
Measured: 3 months
Change in sensory specific satiety for protein, lipid and glucid foods
Measured: 3 months
Change in gustative detection thresholds for sweet, bitter and salty tastes
Measured: 3 months
Change in appetite, desire to eat, pleasure in eating
Measured: 3 months
Secondary outcomes (2)
Change in body mass composition (Dual Energy XRay Absorptiometry)
Measured: 3 months
Change in plasma ghrelin, leptin, and HbA1c levels
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startJan 2011
- Primary completionJan 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Claude Brindisi, Centre Hospitalier Universitaire Dijon
- Investigators
- Marie-Claude Brindisi, MD, Principal investigator, CHU Dijon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599338
- Sponsor's protocol ID
- A100991-10
- Other IDs
- 2010-022618-19
- Status last verified
- May 2012
- First submitted
- 14 May 2012
- Last updated
- 1 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence du Victoza (Liraglutide,Analogue GLP-1) Sur Les Performances Gustatives, le Rassasiement Sensoriel spécifique, le Liking et le Wanting Chez Les Patients diabétiques de Type 2.
- ClinicalTrials.gov ID
- NCT01599338
- Acronym / sponsor ID
- A100991-10
- Conditions
- Type 2 Diabetes Mellitus, Overweight
- Keywords
- Liraglutide, GLP-1 analogue, Food preference, Gustative perception, Liking, wanting, T2DM, body mass composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 16 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | Experimental | Drug: LiraglutideSingle Arm study. T2DM patients are studied before and after 3 months of Liraglutide treatment (1.2 mg/day). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetic patients
- with glycemic unbalance despite anti-diabetic treatments and
- overweight (BMI > 25 kg/m²)
Key exclusion criteria (12 listed)
- Impaired renal function (creatinine clearance < 50 ml/min),
- Pregnancy,
- Congestive heart failure,
- Acute and chronic infection,
- Evolutive cancer,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiraglutideAlso: Novonordisk (Puteaux, France)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. | Drug | Liraglutide |
Primary outcome
Change in liking and wanting for protein, lipid and glucid foods
Time frame: 3 months
Change in sensory specific satiety for protein, lipid and glucid foods
Time frame: 3 months
Change in gustative detection thresholds for sweet, bitter and salty tastes
Time frame: 3 months
Change in appetite, desire to eat, pleasure in eating
Time frame: 3 months
2 secondary outcomes
Change in body mass composition (Dual Energy XRay Absorptiometry)
Time frame: 3 months
Change in plasma ghrelin, leptin, and HbA1c levels
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Claude Brindisi, MD principal investigator
CHU Dijon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liraglutide in people with Type 2 Diabetes Mellitus and Overweight, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in liking and wanting for protein, lipid and glucid foods (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2012; AzTrials last refreshed its copy on 8 Nov 2026.