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NCT Number: NCT04613791

Situation and Evolution of the Misuse of Alcohol and Other Addictive Behaviors in Obese Patients Being Managed at Nîmes University Hospital

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nimes

Nîmes, France

Location status: Recruiting

Location contact

Anissa Megzari

CONTACT

[email protected]

04.66.68.42.36

Emma LUCQUIAUD, Dr.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

blood test

Biological

Collection of epidemio-clinical, biological, radiological and therapeutic patient data. Study samples collected from 154 patients to determine whether a particular immune profile could identify individuals prone to insulin resistance

Other names: Distribution of the following questionnaires: AUDIT, CAST, HADS, BES, Fagerstrom test and the EQVOD scale

Primary outcomes

  1. Presence of alcohol abuse evaluated at the first clinical consultation according to the AUDIT(Alcohol Use Disorders Identification Test) questionnaire.

    Time frame: Day 0

    The Alcohol Use Disorders Identification Test (AUDIT) self-questionnaire consists of 10 questions covering consumption (the first 3 questions), behaviors that may evoke dependency (not being able to stop drinking, inability to carry out one's plans, needing a drink in the morning) and problems related to alcohol consumption (guilt or remorse, memory loss, injuries, concerns from family and friends). Each question can be scored from 0 (low) - 4 (high) points, leading to a possible total score of 40 points. This questionnaire therefore makes it possible to cover all aspects of alcohol misuse in a very short space of time. It has been validated with good diagnostic performance: sensitivity at 92% and specificity at 94% for a threshold ≥ 8 (Saunders et al. 1993; Coulton et al. 2006). Moreover, this questionnaire is very widely used and recognized in scientific articles on addictology.

  2. Presence of alcohol abuse evaluated at the first clinical consultation according to the AUDIT(Alcohol Use Disorders Identification Test) questionnaire.

    Time frame: Month 12

    The Alcohol Use Disorders Identification Test (AUDIT) self-questionnaire consists of 10 questions covering consumption (the first 3 questions), behaviors that may evoke dependency (not being able to stop drinking, inability to carry out one's plans, needing a drink in the morning) and problems related to alcohol consumption (guilt or remorse, memory loss, injuries, concerns from family and friends).Each question can be scored from 0 (low) - 4 (high) points, leading to a possible total score of 40 points. This questionnaire therefore makes it possible to cover all aspects of alcohol misuse in a very short space of time. It has been validated with good diagnostic performance: sensitivity at 92% and specificity at 94% for a threshold ≥ 8 (Saunders et al. 1993; Coulton et al. 2006). Moreover, this questionnaire is very widely used and recognized in scientific articles on addictology.

  3. Presence of alcohol abuse evaluated at the first clinical consultation according to the AUDIT(Alcohol Use Disorders Identification Test) questionnaire.

    Time frame: Month 24

    The Alcohol Use Disorders Identification Test (AUDIT) self-questionnaire consists of 10 questions covering consumption (the first 3 questions), behaviors that may evoke dependency (not being able to stop drinking, inability to carry out one's plans, needing a drink in the morning) and problems related to alcohol consumption (guilt or remorse, memory loss, injuries, concerns from family and friends). Each question can be scored from 0 (low) - 4 (high) points, leading to a possible total score of 40 points.This questionnaire therefore makes it possible to cover all aspects of alcohol misuse in a very short space of time. It has been validated with good diagnostic performance: sensitivity at 92% and specificity at 94% for a threshold ≥ 8 (Saunders et al. 1993; Coulton et al. 2006). Moreover, this questionnaire is very widely used and recognized in scientific articles on addictology.

  4. Presence of alcohol abuse evaluated at the first clinical consultation according to the DSM-5 questionnaire

    Time frame: Day 0

    The DSM-5 criteria are used to identify depression in all patients with high alcohol consumption (over14 glasses a week for women, 21 for men, or more than 4 glasses on one occasion). The DSM-5 outlines the following criterion to make a diagnosis of depression. The individual must be experiencing five or more symptoms during the same 2-week period and at least one of the symptoms should be either (1) depressed mood or (2) loss of interest or pleasure.

  5. Presence of alcohol abuse evaluated at the first clinical consultation according to the DSM-5 questionnaire

    Time frame: Month 12

    The DSM-5 criteria are used to identify depression in all patients with high alcohol consumption (over14 glasses a week for women, 21 for men, or more than 4 glasses on one occasion). The DSM-5 outlines the following criterion to make a diagnosis of depression. The individual must be experiencing five or more symptoms during the same 2-week period and at least one of the symptoms should be either (1) depressed mood or (2) loss of interest or pleasure.

  6. Presence of alcohol abuse evaluated at the first clinical consultation according to the DSM-5 questionnaire

    Time frame: Month 24

    The DSM-5 criteria are used to identify depression in all patients with high alcohol consumption (over14 glasses a week for women, 21 for men, or more than 4 glasses on one occasion). The DSM-5 outlines the following criterion to make a diagnosis of depression. The individual must be experiencing five or more symptoms during the same 2-week period and at least one of the symptoms should be either (1) depressed mood or (2) loss of interest or pleasure.

Secondary outcomes

  1. Smoking (tobacco addiction) according to the Fagerström test

    Time frame: Day 0

    The Fagerström test consists of six questions. A score of 0 - 10 is obtained depending on the answers given. A score of 0 - 2 = zero addiction, 3 - 4 = slight addiction, 5 - 6 = moderate addiction, 7 ou 8 heavy addiction and 9 - 10 = very heavy addiction.

  2. Smoking (tobacco addiction) according to the Fagerström test

    Time frame: Month 12

    The Fagerström test consists of six questions. A score of 0 - 10 is obtained depending on the answers given. A score of 0 - 2 = zero addiction, 3 - 4 = slight addiction, 5 - 6 = moderate addiction, 7 ou 8 heavy addiction and 9 - 10 = very heavy addiction.

  3. Smoking (tobacco addiction) according to the Fagerström test

    Time frame: Month 24

    The Fagerström test consists of six questions. A score of 0 - 10 is obtained depending on the answers given. A score of 0 - 2 = zero addiction, 3 - 4 = slight addiction, 5 - 6 = moderate addiction, 7 ou 8 heavy addiction and 9 - 10 = very heavy addiction.

  4. Cannabis addiction

    Time frame: Day 0

    The Cannabis Abuse Screening Test (CAST) questionnaire has 6 questions to which the answer YES (=1) or NO (=0) is given. A score ≥ 3 on the CAST indicates addiction to Cannabis.

  5. Cannabis addiction

    Time frame: Month 12

    The Cannabis Abuse Screening Test (CAST) questionnaire has 6 questions to which the answer YES (=1) or NO (=0) is given. A score ≥ 3 on the CAST indicates addiction to Cannabis.

  6. Cannabis addiction

    Time frame: Month 24

    The Cannabis Abuse Screening Test (CAST) questionnaire has 6 questions to which the answer YES (=1) or NO (=0) is given. A score ≥ 3 on the CAST indicates addiction to Cannabis.

  7. Use of cocaine

    Time frame: Day 0

    The patient will be interviewed to find out whether he/she uses cocaine. This will be noted as Yes/No

  8. Use of cocaine

    Time frame: Month 12

    The patient will be interviewed to find out whether he/she uses cocaine. This will be noted as Yes/No

  9. Use of cocaine

    Time frame: Month 24

    The patient will be interviewed to find out whether he/she uses cocaine. This will be noted as Yes/No

  10. Use of amphetamines

    Time frame: Day 0

    The patient will be interviewed to find out whether he/she uses amphetamines. This will be noted as Yes/No

  11. Use of amphetamines

    Time frame: Month 12

    The patient will be interviewed to find out whether he/she uses amphetamines. This will be noted as Yes/No

  12. Use of amphetamines

    Time frame: Month 24

    The patient will be interviewed to find out whether he/she uses amphetamines. This will be noted as Yes/No

  13. Use of opioids

    Time frame: Day 0

    The patient will be interviewed to find out whether he/she uses opioids. This will be noted as Yes/No

  14. Use of opioids

    Time frame: Month 12

    The patient will be interviewed to find out whether he/she uses opioids. This will be noted as Yes/No

  15. Use of opioids

    Time frame: Month 24

    The patient will be interviewed to find out whether he/she uses opioids. This will be noted as Yes/No

  16. Use of hallucinogenic drugs and/or new synthetic drugs

    Time frame: Day 0

    The patient will be interviewed to find out whether he/she uses hallucinogenic drugs and/or new synthetic drugs. This will be noted as Yes/No

  17. Use of hallucinogenic drugs and/or new synthetic drugs

    Time frame: Month 12

    The patient will be interviewed to find out whether he/she uses hallucinogenic drugs and/or new synthetic drugs. This will be noted as Yes/No

  18. Use of hallucinogenic drugs and/or new synthetic drugs

    Time frame: Month 24

    The patient will be interviewed to find out whether he/she uses hallucinogenic drugs and/or new synthetic drugs. This will be noted as Yes/No

  19. Eating disorders

    Time frame: Day 0

    A score ≥ 17 on the BES (Binge Eating Scale) questionnaire indicates presence of an eating disorder.

  20. Eating disorders

    Time frame: Month 12

    A score ≥ 17 on the BES (Binge Eating Scale) questionnaire indicates presence of an eating disorder.

  21. Eating disorders

    Time frame: Month 24

    A score ≥ 17 on the BES (Binge Eating Scale) questionnaire indicates presence of an eating disorder.

  22. Comorbidities

    Time frame: Day 0

    Presence of comorbidities for obesity (High blood pressure / Glucose intolerance or Diabetes / Sleep apnea syndrome / Dyslipidemia / Hepatic Steatosis / Cardiovascular diseases) will be noted from data in the patient file.

  23. Comorbidities

    Time frame: Month 12

    Presence of comorbidities for obesity (High blood pressure / Glucose intolerance or Diabetes / Sleep apnea syndrome / Dyslipidemia / Hepatic Steatosis / Cardiovascular diseases) will be noted from data in the patient file.

  24. Comorbidities

    Time frame: Month 24

    Presence of comorbidities for obesity (High blood pressure / Glucose intolerance or Diabetes / Sleep apnea syndrome / Dyslipidemia / Hepatic Steatosis / Cardiovascular diseases) will be noted from data in the patient file.

  25. Quality of Life according to the EQVOD scale

    Time frame: Day 0

    The "Echelle de Qualité de Vie, Obésité et Diététique - EQVOD" (Quality of Life, Obesity and Dietetics Scale ) is a self-questionnaire validated in French which is adapted to the socio-cultural factors of obesity in France, making it possible to take into account the effects of dietary treatments on the quality of life of obese subjects (see Appendix 17.5) (Ziegler et al. 2005). It consists of 36 items, rated from 1 (always/highly) to 5 (never/not at all). It explores five dimensions (physical impact - Q1-Q11, psychosocial impact - Q12-Q22, impact on sexual life - Q23-Q26, food well-being - Q27-Q31 and diet experience - Q32-Q36). The rating for each dimension is reported as 100. The closer the score is to 100, the better the quality of life related to that dimension.

  26. Quality of Life according to the EQVOD scale

    Time frame: Month 12

    The "Echelle de Qualité de Vie, Obésité et Diététique - EQVOD" (Quality of Life, Obesity and Dietetics Scale ) is a self-questionnaire validated in French which is adapted to the socio-cultural factors of obesity in France, making it possible to take into account the effects of dietary treatments on the quality of life of obese subjects (see Appendix 17.5) (Ziegler et al. 2005). It consists of 36 items, rated from 1 (always/highly) to 5 (never/not at all). It explores five dimensions (physical impact - Q1-Q11, psychosocial impact - Q12-Q22, impact on sexual life - Q23-Q26, food well-being - Q27-Q31 and diet experience - Q32-Q36). The rating for each dimension is reported as 100. The closer the score is to 100, the better the quality of life related to that dimension.

  27. Quality of Life according to the EQVOD scale

    Time frame: Month 24

    The "Echelle de Qualité de Vie, Obésité et Diététique - EQVOD" (Quality of Life, Obesity and Dietetics Scale ) is a self-questionnaire validated in French which is adapted to the socio-cultural factors of obesity in France, making it possible to take into account the effects of dietary treatments on the quality of life of obese subjects (see Appendix 17.5) (Ziegler et al. 2005). It consists of 36 items, rated from 1 (always/highly) to 5 (never/not at all). It explores five dimensions (physical impact - Q1-Q11, psychosocial impact - Q12-Q22, impact on sexual life - Q23-Q26, food well-being - Q27-Q31 and diet experience - Q32-Q36). The rating for each dimension is reported as 100. The closer the score is to 100, the better the quality of life related to that dimension.

  28. Anxiety and Depression

    Time frame: Day 0

    The Hospital Anxiety and Depression Scale (HADS) is a self-report questionnaire that assesses depressive and anxiety symptomatology (excluding somatic symptoms) and measures severity in patients between 16 and 65 years of age from a hospital environment (Zigmong & Snaith 1983, Snaith et al. 2003). The HADS consists of two parts: (a) 7 questions for screening for depression, and (b) 7 questions for screening for anxiety disorders. Each question receives a score between 0 and 3. The score for each part is obtained by adding the items that make up the part. The higher the score, the greater the severity of the corresponding symptoms.

    The French version was validated by Razavi et al. 1989 and Friedman et al. 2001.

  29. Anxiety and Depression

    Time frame: Month 12

    The Hospital Anxiety and Depression Scale (HADS) is a self-report questionnaire that assesses depressive and anxiety symptomatology (excluding somatic symptoms) and measures severity in patients between 16 and 65 years of age from a hospital environment (Zigmong & Snaith 1983, Snaith et al. 2003). The HADS consists of two parts: (a) 7 questions for screening for depression, and (b) 7 questions for screening for anxiety disorders. Each question receives a score between 0 and 3. The score for each part is obtained by adding the items that make up the part. The higher the score, the greater the severity of the corresponding symptoms.

    The French version was validated by Razavi et al. 1989 and Friedman et al. 2001.

  30. Anxiety and Depression

    Time frame: Month 24

    The Hospital Anxiety and Depression Scale (HADS) is a self-report questionnaire that assesses depressive and anxiety symptomatology (excluding somatic symptoms) and measures severity in patients between 16 and 65 years of age from a hospital environment (Zigmong & Snaith 1983, Snaith et al. 2003). The HADS consists of two parts: (a) 7 questions for screening for depression, and (b) 7 questions for screening for anxiety disorders. Each question receives a score between 0 and 3. The score for each part is obtained by adding the items that make up the part. The higher the score, the greater the severity of the corresponding symptoms.

    The French version was validated by Razavi et al. 1989 and Friedman et al. 2001.

  31. Binge eating

    Time frame: Day 0

    The Binge Eating Scale (BES) is a self-administered questionnaire that diagnoses Binge Eating Disorder (BED) and assesses the behavioural, emotional and cognitive symptoms associated with Binge Eating Disorder in obese individuals (Gormally et al. 1982). It is composed of 16 items corresponding to groups of sentences including one to be selected from 3 to 4 propositions, which best describe how one feels. For each item, the subject has to choose the formulation that best corresponds to his current situation, which results in a score varying between 0 and 3 or between 0 and 2 for each item. Half of the items measure eating behaviours and the other half assess feelings or cognitions occurring during compulsive episodes. It gives a total score (from 0 to 46) that reflects the severity of the BED. A score greater than or equal to 18 indicates significant bulimic hyperphagia. The French version of this questionnaire was translated and validated by Brunault et al (2016).

  32. Binge eating

    Time frame: Month 12

    The Binge Eating Scale (BES) is a self-administered questionnaire that diagnoses Binge Eating Disorder (BED) and assesses the behavioural, emotional and cognitive symptoms associated with Binge Eating Disorder in obese individuals (Gormally et al. 1982). It is composed of 16 items corresponding to groups of sentences including one to be selected from 3 to 4 propositions, which best describe how one feels. For each item, the subject has to choose the formulation that best corresponds to his current situation, which results in a score varying between 0 and 3 or between 0 and 2 for each item. Half of the items measure eating behaviours and the other half assess feelings or cognitions occurring during compulsive episodes. It gives a total score (from 0 to 46) that reflects the severity of the BED. A score greater than or equal to 18 indicates significant bulimic hyperphagia. The French version of this questionnaire was translated and validated by Brunault et al (2016).

  33. Binge eating

    Time frame: Month 24

    The Binge Eating Scale (BES) is a self-administered questionnaire that diagnoses Binge Eating Disorder (BED) and assesses the behavioural, emotional and cognitive symptoms associated with Binge Eating Disorder in obese individuals (Gormally et al. 1982). It is composed of 16 items corresponding to groups of sentences including one to be selected from 3 to 4 propositions, which best describe how one feels. For each item, the subject has to choose the formulation that best corresponds to his current situation, which results in a score varying between 0 and 3 or between 0 and 2 for each item. Half of the items measure eating behaviours and the other half assess feelings or cognitions occurring during compulsive episodes. It gives a total score (from 0 to 46) that reflects the severity of the BED. A score greater than or equal to 18 indicates significant bulimic hyperphagia. The French version of this questionnaire was translated and validated by Brunault et al (2016).

Other outcomes

  1. Age

    Time frame: Day 0

    Age will be recorded in years

  2. Age

    Time frame: Month 12

    Age will be recorded in years

  3. Age

    Time frame: Month 24

    Age will be recorded in years

  4. Weight

    Time frame: Day 0

    Weight will be recorded in kg.

  5. Weight

    Time frame: Month 12

    Weight will be recorded in kg.

  6. Weight

    Time frame: Month 24

    Weight will be recorded in kg.

  7. Height

    Time frame: Day 0

    Height will be recorded in cm

  8. Height

    Time frame: Month 12

    Height will be recorded in cm

  9. Height

    Time frame: Month 24

    Height will be recorded in cm

  10. Sex

    Time frame: Day 0

    Male/Female

  11. Sex

    Time frame: Month 12

    Male/Female

  12. Sex

    Time frame: Month 24

    Male/Female

  13. Other relevant items

    Time frame: Day 0

    All items (X-rays, biological tests, medicinal treatment…) relevant to the patient's care will be noted

  14. Other relevant items

    Time frame: Month 12

    All items (X-rays, biological tests, medicinal treatment…) relevant to the patient's care will be noted

  15. Other relevant items

    Time frame: Month 24

    All items (X-rays, biological tests, medicinal treatment…) relevant to the patient's care will be noted

  16. Insulinemia only in the immun-Adob subpopulation

    Time frame: Day 0 and Month 12

    Method of determining insulin levels

  17. Homa index in the Immun-Adob subpopulation

    Time frame: Day 0 and Month 12

    Blood glucose measurement that is routine test

  18. Presence of waist circumference criterion ≥ 94 cm in men, ≥ 80 cm in women or BMI > 30 kg/m²

    Time frame: Day 0

    clinically determined visceral obesity

  19. Triglyceride levels ≥ 1.5 G/L or treatment

    Time frame: Day 0

    Triglyceride measurements that are routine tests

  20. Low HDL levels < 0.40g/L in men and < 0.50 in women or treatment

    Time frame: Day 0

    HDL measurement which is a routine biological analysis.

  21. High blood pressure SBP ≥ 130 mmHg or DBP ≥ 85 mmHg or treatment.

    Time frame: Day 0

    Hypertension is determined clinically

  22. Fasting blood glucose ≥ 1g/L

    Time frame: Day 0

    Glucose intolerance measurement which is a routine biological test.

  23. Therelationship between membership in the immune activation profile of hyperinsulinism and the evolution of insulin levels

    Time frame: Between Day 0 and Month 12

    The percentages of CD57+, PD-1+, CD38+, HLA-DR+, naive or memory T4 or T8 cells will be determined by flow cytometry

  24. The link between belonging to the immune activation profile of hyperinsulinism and the evolution of the HOMA index

    Time frame: Between Day 0 and Month 12

    The percentages of CD57+, PD-1+, CD38+, HLA-DR+, naive or memory T4 or T8 cells will be determined by flow cytometry

  25. The link between the membership to the immune activation profile of hyperinsulinism and the evolution of the metabolic syndrome

    Time frame: Between Day 0 and Month 12

Study contacts

Contact information is provided by the study sponsor or research team.

Anissa MEGZARI

CONTACT

[email protected]

+33 4.66.68.42.36

Emma LUCQUIAUD, Dr.

CONTACT

[email protected]

+33 4.66.68.33.21

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: ADOB

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 3, 2020
Registry last updated
Jun 16, 2026

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