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

Obesity Clinical Trial

— ADOB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04613791
• Other study ID #: NIMAO/2019-2/FB-01
• Status: Recruiting
• Start date: February 16, 2021
• Est. completion date: December 15, 2023

Study information

• Verified date: January 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Emma LUCQUIAUD, Dr.
• Phone: +33 4.66.68.33.21
• Email: emma.lucquiaud[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Behavior, Addictive
• Obesity

Intervention

Biological:
• Blood test
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

Locations

Country	Name	City	State
France	CHU de Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age	Age will be recorded in years	Day 0
Other	Age	Age will be recorded in years	Month 12
Other	Age	Age will be recorded in years	Month 24
Other	Weight	Weight will be recorded in kg.	Day 0
Other	Weight	Weight will be recorded in kg.	Month 12
Other	Weight	Weight will be recorded in kg.	Month 24
Other	Height	Height will be recorded in cm	Day 0
Other	Height	Height will be recorded in cm	Month 12
Other	Height	Height will be recorded in cm	Month 24
Other	Sex	Male/Female	Day 0
Other	Sex	Male/Female	Month 12
Other	Sex	Male/Female	Month 24
Other	Other relevant items	All items (X-rays, biological tests, medicinal treatment…) relevant to the patient's care will be noted	Day 0
Other	Other relevant items	All items (X-rays, biological tests, medicinal treatment…) relevant to the patient's care will be noted	Month 12
Other	Other relevant items	All items (X-rays, biological tests, medicinal treatment…) relevant to the patient's care will be noted	Month 24
Other	Insulinemia only in the immun-Adob subpopulation	Method of determining insulin levels	Day 0 and Month 12
Other	Homa index in the Immun-Adob subpopulation	Blood glucose measurement that is routine test	Day 0 and Month 12
Other	Presence of waist circumference criterion = 94 cm in men, = 80 cm in women or BMI > 30 kg/m²	clinically determined visceral obesity	Day 0
Other	Triglyceride levels = 1.5 G/L or treatment	Triglyceride measurements that are routine tests	Day 0
Other	Low HDL levels < 0.40g/L in men and < 0.50 in women or treatment	HDL measurement which is a routine biological analysis.	Day 0
Other	High blood pressure SBP = 130 mmHg or DBP = 85 mmHg or treatment.	Hypertension is determined clinically	Day 0
Other	Fasting blood glucose = 1g/L	Glucose intolerance measurement which is a routine biological test.	Day 0
Other	Therelationship between membership in the immune activation profile of hyperinsulinism and the evolution of insulin levels	The percentages of CD57+, PD-1+, CD38+, HLA-DR+, naive or memory T4 or T8 cells will be determined by flow cytometry	Between Day 0 and Month 12
Other	The link between belonging to the immune activation profile of hyperinsulinism and the evolution of the HOMA index	The percentages of CD57+, PD-1+, CD38+, HLA-DR+, naive or memory T4 or T8 cells will be determined by flow cytometry	Between Day 0 and Month 12
Other	The link between the membership to the immune activation profile of hyperinsulinism and the evolution of the metabolic syndrome		Between Day 0 and Month 12
Primary	Presence of alcohol abuse evaluated at the first clinical consultation according to the AUDIT(Alcohol Use Disorders Identification Test) questionnaire.	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.	Day 0
Primary	Presence of alcohol abuse evaluated at the first clinical consultation according to the AUDIT(Alcohol Use Disorders Identification Test) questionnaire.	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.	Month 12
Primary	Presence of alcohol abuse evaluated at the first clinical consultation according to the AUDIT(Alcohol Use Disorders Identification Test) questionnaire.	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.	Month 24
Primary	Presence of alcohol abuse evaluated at the first clinical consultation according to the DSM-5 questionnaire	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.	Day 0
Primary	Presence of alcohol abuse evaluated at the first clinical consultation according to the DSM-5 questionnaire	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.	Month 12
Primary	Presence of alcohol abuse evaluated at the first clinical consultation according to the DSM-5 questionnaire	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.	Month 24
Secondary	Smoking (tobacco addiction) according to the Fagerström test	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.	Day 0
Secondary	Smoking (tobacco addiction) according to the Fagerström test	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.	Month 12
Secondary	Smoking (tobacco addiction) according to the Fagerström test	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.	Month 24
Secondary	Cannabis addiction	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.	Day 0
Secondary	Cannabis addiction	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.	Month 12
Secondary	Cannabis addiction	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.	Month 24
Secondary	Use of cocaine	The patient will be interviewed to find out whether he/she uses cocaine. This will be noted as Yes/No	Day 0
Secondary	Use of cocaine	The patient will be interviewed to find out whether he/she uses cocaine. This will be noted as Yes/No	Month 12
Secondary	Use of cocaine	The patient will be interviewed to find out whether he/she uses cocaine. This will be noted as Yes/No	Month 24
Secondary	Use of amphetamines	The patient will be interviewed to find out whether he/she uses amphetamines. This will be noted as Yes/No	Day 0
Secondary	Use of amphetamines	The patient will be interviewed to find out whether he/she uses amphetamines. This will be noted as Yes/No	Month 12
Secondary	Use of amphetamines	The patient will be interviewed to find out whether he/she uses amphetamines. This will be noted as Yes/No	Month 24
Secondary	Use of opioids	The patient will be interviewed to find out whether he/she uses opioids. This will be noted as Yes/No	Day 0
Secondary	Use of opioids	The patient will be interviewed to find out whether he/she uses opioids. This will be noted as Yes/No	Month 12
Secondary	Use of opioids	The patient will be interviewed to find out whether he/she uses opioids. This will be noted as Yes/No	Month 24
Secondary	Use of hallucinogenic drugs and/or new synthetic drugs	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	Day 0
Secondary	Use of hallucinogenic drugs and/or new synthetic drugs	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	Month 12
Secondary	Use of hallucinogenic drugs and/or new synthetic drugs	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	Month 24
Secondary	Eating disorders	A score = 17 on the BES (Binge Eating Scale) questionnaire indicates presence of an eating disorder.	Day 0
Secondary	Eating disorders	A score = 17 on the BES (Binge Eating Scale) questionnaire indicates presence of an eating disorder.	Month 12
Secondary	Eating disorders	A score = 17 on the BES (Binge Eating Scale) questionnaire indicates presence of an eating disorder.	Month 24
Secondary	Comorbidities	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.	Day 0
Secondary	Comorbidities	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.	Month 12
Secondary	Comorbidities	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.	Month 24
Secondary	Quality of Life according to the EQVOD scale	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.	Day 0
Secondary	Quality of Life according to the EQVOD scale	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.	Month 12
Secondary	Quality of Life according to the EQVOD scale	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.	Month 24
Secondary	Anxiety and Depression	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.	Day 0
Secondary	Anxiety and Depression	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.	Month 12
Secondary	Anxiety and Depression	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.	Month 24
Secondary	Binge eating	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).	Day 0
Secondary	Binge eating	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).	Month 12
Secondary	Binge eating	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).	Month 24