Clinical trial NCT04613791: Situation and Evolution of the Misuse of Alcohol and Other Addictive Behaviors in Obese Patients Being Managed at Nîmes University Hospital
Official title: Situation and Evolution of the Misuse of Alcohol and Other Addictive Behaviors in Obese Patients Being Managed at Nîmes University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population for this study corresponds to all patients being managed for obesity (Body Mass Index ≥ 30 kg.m-²).

The source population for this study corresponds to all patients being managed by the obesity clinic at Nîmes University Hospital for obesity with a BMI ≥ 30 kg.m-² at the time of their first visit (complete hospitalization outpatients or consultation) for initiation to management (incident subjects).

Brief summary: Obesity is a multifactorial pathology in which external (lifestyle, environment) and internal (psychological or biological, especially genetic) factors are involved. These are responsible for a positive energy balance. One of the external factors that can intervene in the genesis of obesity is the existence of eating disorders: bulimic hyperphagia. Some teams consider bulimic hyperphagia as a form of addiction. After bariatric surgery, the appearance of new addictions has been observed.

In connection with Pr Perney's addictology department, the investigators have observed that some patients under treatment for obesity at the endocrinology department subsequently developed other addictions, in particular misuse of alcohol.

The hypotheses of this research are :

There appears to be a transfer from eating disorders to substance misuse addiction in post-treatment of obesity, particularly in patients who have undergone bariatric surgery.

The misuse of addictive substances most concerned by this transfer of addiction in the post-treatment of obesity, particularly after bariatric surgery, seems to be the misuse of alcohol.

This will be the first French cohort study on addictive behaviors in patients undergoing bariatric surgery and the first international study including non-operated obese patients benefiting from medical care alone. This study will improve the multidisciplinary management of these patients by integrating addictologists.


Eligibility criteria: * Patient being managed for the first time at Nîmes University Hospital Obesity Clinic ( complete hospitalization, outpatients' or consultation).
* Patient being managed for obesity defined by a body mass index (BMI) of 30 kg.m-² or over
* Patient affiliated to or covered by a health insurance scheme.
* Adult patient (≥ 18 years).

Exclusion Criteria:

* Patient with psychiatric disorder reducing capacity for comprehension.
* Patient in an exclusion period determined by another study.
* Patient under legal guardianship, tutorship or curatorship.
* Patient to whom it is impossible to give clear information
* Patient who is pregnant, about to give birth or breastfeeding.

Primary outcomes:
measure: Presence of alcohol abuse evaluated at the first clinical consultation according to the AUDIT(Alcohol Use Disorders Identification Test) questionnaire.
timeFrame: Day 0
measure: Presence of alcohol abuse evaluated at the first clinical consultation according to the AUDIT(Alcohol Use Disorders Identification Test) questionnaire.
timeFrame: Month 12
measure: Presence of alcohol abuse evaluated at the first clinical consultation according to the AUDIT(Alcohol Use Disorders Identification Test) questionnaire.
timeFrame: Month 24
measure: Presence of alcohol abuse evaluated at the first clinical consultation according to the DSM-5 questionnaire
timeFrame: Day 0
measure: Presence of alcohol abuse evaluated at the first clinical consultation according to the DSM-5 questionnaire
timeFrame: Month 12
measure: Presence of alcohol abuse evaluated at the first clinical consultation according to the DSM-5 questionnaire
timeFrame: Month 24
Secondary outcomes:
measure: Smoking (tobacco addiction) according to the Fagerström test
timeFrame: Day 0
measure: Smoking (tobacco addiction) according to the Fagerström test
timeFrame: Month 12
measure: Smoking (tobacco addiction) according to the Fagerström test
timeFrame: Month 24
measure: Cannabis addiction
timeFrame: Day 0
measure: Cannabis addiction
timeFrame: Month 12
measure: Cannabis addiction
timeFrame: Month 24
measure: Use of cocaine
timeFrame: Day 0
measure: Use of cocaine
timeFrame: Month 12
measure: Use of cocaine
timeFrame: Month 24
measure: Use of amphetamines
timeFrame: Day 0
measure: Use of amphetamines
timeFrame: Month 12
measure: Use of amphetamines
timeFrame: Month 24
measure: Use of opioids
timeFrame: Day 0
measure: Use of opioids
timeFrame: Month 12
measure: Use of opioids
timeFrame: Month 24
measure: Use of hallucinogenic drugs and/or new synthetic drugs
timeFrame: Day 0
measure: Use of hallucinogenic drugs and/or new synthetic drugs
timeFrame: Month 12
measure: Use of hallucinogenic drugs and/or new synthetic drugs
timeFrame: Month 24
measure: Eating disorders
timeFrame: Day 0
measure: Eating disorders
timeFrame: Month 12
measure: Eating disorders
timeFrame: Month 24
measure: Comorbidities
timeFrame: Day 0
measure: Comorbidities
timeFrame: Month 12
measure: Comorbidities
timeFrame: Month 24
measure: Quality of Life according to the EQVOD scale
timeFrame: Day 0
measure: Quality of Life according to the EQVOD scale
timeFrame: Month 12
measure: Quality of Life according to the EQVOD scale
timeFrame: Month 24
measure: Anxiety and Depression
timeFrame: Day 0
measure: Anxiety and Depression
timeFrame: Month 12
measure: Anxiety and Depression
timeFrame: Month 24
measure: Binge eating
timeFrame: Day 0
measure: Binge eating
timeFrame: Month 12
measure: Binge eating
timeFrame: Month 24
Other outcomes:
measure: Age
timeFrame: Day 0
measure: Age
timeFrame: Month 12
measure: Age
timeFrame: Month 24
measure: Weight
timeFrame: Day 0
measure: Weight
timeFrame: Month 12
measure: Weight
timeFrame: Month 24
measure: Height
timeFrame: Day 0
measure: Height
timeFrame: Month 12
measure: Height
timeFrame: Month 24
measure: Sex
timeFrame: Day 0
measure: Sex
timeFrame: Month 12
measure: Sex
timeFrame: Month 24
measure: Other relevant items
timeFrame: Day 0
measure: Other relevant items
timeFrame: Month 12
measure: Other relevant items
timeFrame: Month 24
measure: Insulinemia only in the immun-Adob subpopulation
timeFrame: Day 0 and Month 12
measure: Homa index in the Immun-Adob subpopulation
timeFrame: Day 0 and Month 12
measure: Presence of waist circumference criterion ≥ 94 cm in men, ≥ 80 cm in women or BMI > 30 kg/m²
timeFrame: Day 0
measure: Triglyceride levels ≥ 1.5 G/L or treatment
timeFrame: Day 0
measure: Low HDL levels < 0.40g/L in men and < 0.50 in women or treatment
timeFrame: Day 0
measure: High blood pressure SBP ≥ 130 mmHg or DBP ≥ 85 mmHg or treatment.
timeFrame: Day 0
measure: Fasting blood glucose ≥ 1g/L
timeFrame: Day 0
measure: Therelationship between membership in the immune activation profile of hyperinsulinism and the evolution of insulin levels
timeFrame: Between Day 0 and Month 12
measure: The link between belonging to the immune activation profile of hyperinsulinism and the evolution of the HOMA index
timeFrame: Between Day 0 and Month 12
measure: The link between the membership to the immune activation profile of hyperinsulinism and the evolution of the metabolic syndrome
timeFrame: Between Day 0 and Month 12
Locations:
city: Nîmes
country: France
facility: CHU de Nimes
Study officials:
References: