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Influence of genetic variants in weight-control after bariatric surgery

Influence of brain-gut axis GENe variants in the response to BARiatric surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN80961259
Enrollment
520
Registered
2019-06-10
Start date
2009-04-01
Completion date
Unknown
Last updated
2023-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity Nutritional, Metabolic, Endocrine

Interventions

This study includes bariatric surgery candidates with different degrees of intestinal malabsorption (gastric bypass, biliopancreatic derivation) or restriction (sleeve gastrectomy), according to the c

Sponsors

Instituto de Investigación Sanitaria del Hospital Clínico San Carlos.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Cases: 1. Men and women with ages between 18-65 years 2. BMI = 40 kg/m² (men) or = 35 kg/m² (women) with at least one major comorbidities (type 2 diabetes, hypertension, hyperlipemia, sleep obstructive apnea) 3. Absence of serious disease (chronic kidney disease, liver disease, neurological disease) 4. Absence of psychiatric pathology 5. Ability to understand the mechanisms involved in the surgery that will be proposed 6. Written informed consent to participate in the study Controls: 1. Men and women with ages between 18-65 years 2. BMI between 18.5-24.9 kg/m² 3. Absence of comorbidities 4. Absence of serious disease (chronic kidney disease, liver disease, neurological disease) 5. Absence of psychiatric pathology 6. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Systematic disease not associated with obesity (inflammatory bowel disease, inflammatory rheumatic disease…) 2. Hepatitis C, known cirrhosis (or discovered during the study) 3. HIV 4. Drug and/or alcohol abuse 5. Eating disorders 6. Pregnancy or breastfeeding 7. Psychiatric disorders

Design outcomes

Primary

MeasureTime frame
Variation in weight response after bariatric surgery and the correlation with genetic variation. 1. Gene determinations (SNPS polymorphisms) measured using extraction of DNA from peripheral blood samples prior to surgery. The evaluation of the selected SNPs is analysed by allelic discrimination using Taqman® probes. 2. Weight, measured with calibrated electronic scale at 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years; Total weight loss percentage (TWLP), calculated by formula; excess weight loss percentage (EWLP), calculated by formula. Ideal weight calculated for BMI 25 kg/m2.

Secondary

MeasureTime frame
Evolution of comorbidities after bariatric surgery and the correlation with genetic variation. 1. At the time of surgery: age, gender, ethnia, type of surgery, date of surgery, weight, height, BMI, presence of comorbidities (hypertension, diabetes, dyslipidemia, NAFLD, obstructive sleep apnoea syndrome). 2. Remission of comorbidities (hypertension, diabetes, dyslipidemia, NAFLD, obstructive sleep apnoea syndrome).

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026