Effect of Bariatric Surgery on Cognition, Genetics and Lifestyle

NCT02085369 | Unknown

• 1 other identifier: PH2014
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity bariatric surgery patients usually lose more than 50% of their former obesity within a relatively short time (\~ 2 years). There is still a lack of knowledge about underlying psychological and biological mechanisms of decline in body weight. The intention of this project is to investigate whether bariatric surgery is associated with patients' cognitive ability, lifestyle and/or gene expression and metabolomics.

Conditions

Obesity, Morbid

Keywords

Bariatric surgery; Cognitive function; Gene expression; Metabolomics; Obesity; Overweight; Lifestyle

Outcome Measures

Primary Outcomes (1)

• Changes in gene expression profile (a.o. FTO, BDNF) following a standardized meal (before vs. after surgery)

  Gene expression profiling (whole genome analysis, with first interest in FTO and BDNF expression) to assess changes in gene expression before vs. after surgery, and to associate gene expression with weight loss after surgery

  1 year

Secondary Outcomes (1)

• The effect of bariatric surgery on cognitive functioning (inhibitory control, selective attention)

  Measures 1 y, 2 y, and 5 y after surgery.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese patients with bariatric surgery

You may qualify if:

• First bariatric surgery

You may not qualify if:

• More than one surgery

Sponsors & Collaborators

• Uppsala University: lead
• Uppsala University Hospital: collaborator

Study Sites (1)

Uppsala University Hospital

Uppsala, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

A fasted blood sample (50 mL) will be taken before and 2h after a standardized meal. Through epigenetic study, we will analyze the changes in DNA methylation after surgery in genes related to metabolism (at the Science for Life Laboratory (SciLifeLab) with 450K Human Meth arrays). In addition, blood samples from these obese patients analyzed (before and after surgery) after ingestion of a predetermined test meal (for example, high protein) to explore changes in metabolites profile. Metabolites in the samples will be quantified by the SciLifeLab.

MeSH Terms

Conditions

Obesity, Morbid; Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Magnus Sundbom, MD

  Academic Hospital Uppsala

  PRINCIPAL INVESTIGATOR

• Helgi Schiöth, Prof

  Uppsala University

  STUDY DIRECTOR

• Olga Titova, PhD

  Uppsala University

  STUDY DIRECTOR

Central Study Contacts

Magnus Sundbom, MD

CONTACT

magnus.sundbom@akademiska.se

Didi Nordberg, MSc

CONTACT

didi.nordberg@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: March 12, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 8, 2021

Record last verified: 2021-03

Locations

SE (1)