Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02674893 |
Date of registration:
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02/02/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Effect of Victoza on Dietary Preferences and Habit in Patients With Type 2 Diabetes
GLP1 et Goût |
Scientific title:
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Comparative Study of Gustatory Performance, Sensory Specific Satiation, Liking and Wanting in Patients With Type 2 Diabetes |
Date of first enrolment:
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February 4, 2014 |
Target sample size:
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48 |
Recruitment status: |
Terminated |
URL:
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https://clinicaltrials.gov/show/NCT02674893 |
Study type:
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Interventional |
Study design:
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Intervention model: Parallel Assignment.
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Phase:
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Phase 4
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Countries of recruitment
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France
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Key inclusion & exclusion criteria
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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….
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Overweight
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Type 2 Diabetes
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Intervention(s)
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Drug: Liraglutide
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Other: Observation alone
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Primary Outcome(s)
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Modifications in wanting
[Time Frame: Up to 3 months]
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Secondary Outcome(s)
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Anthropometric modifications
[Time Frame: Until 3 months]
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Modifications in salivation following the presentation of foods
[Time Frame: Until 3 months]
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Modifications in gustatory performance
[Time Frame: Until 3 months]
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Modifications in optimal preferences for sweet and fatty tastes
[Time Frame: Until 3 months]
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Modifications in liking
[Time Frame: Until 3 months]
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Secondary ID(s)
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BRINDISI 2013
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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