Polymorphids an mRNA Expression in Obese Genes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anders Thorell, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01708083
First received: October 9, 2012
Last updated: August 21, 2013
Last verified: August 2013
  Purpose

Fat tissue from omenta, thigh and abdomen taken under anesthesia on subjects undergoing laparoscopic surgery, cholecystectomy, reflux surgery or gastric by-pass (GBP).

Are there any difference in polymorphids and/or mRNA expression in genes significant for developing obesity, between normal weight and obese individuals, with or without diabetes typ 2 .

Are there any difference in polymorphids and/or mRNA expression in different types of fat tissue


Condition
Polymorphism
mRNA Expression

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Polymorphids and mRNA Expression in Genes, Significant for Developing Obesity and Typ II Diabetes in Different Types/Localisations of Fat Tissue

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Differences in polymorphids and/or mRNA expression in genes, significant for developing obesity and type 2 diabetes, between patients with normal weight and obesity [ Time Frame: approximatly 30 minutes after start of operation ] [ Designated as safety issue: No ]
    fat biopsy taken from abdomen, omenta and thigh at surgery

  • Difference in polymorphids and/or mRNA expression in different types of fat tissue in patients with normal weight or obesity with or without diabetes type 2 [ Time Frame: approximatly 30 minutes after start of operation ] [ Designated as safety issue: No ]
    fat biopsy; abdomen, omenta and thigh taken at surgery


Biospecimen Retention:   Samples With DNA

biopsys; Fat from oment, thigh and abdomen


Enrollment: 50
Study Start Date: January 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Type 2 Diabetes and BMI>35
Patients with type 2 diabetes and body mass index 35 or more.
BMI>35
Patients undergoing surgery, gastric bypass or cholecystectomy, without diabetes type 2 and body mass index 35 or more
BMI 18-27
Patients undergoing surgery, cholecystectomy or reflux, without type 2 diabetes and body mass index between 18-27

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Tree groups; group I: diabetes type II with BMI>35 Group II: no diabetes BMI>35 Group III: no diabetes BMI 18-27

Criteria

Inclusion Criteria:

  • age 18 years or older
  • laparoscopic surgery (Gastric by-pass, cholecystectomy, antireflux surgery)
  • Normal weight without type 2 diabetes BMI 18-25
  • Obese without type 2 diabetes BMI>35
  • Obese with type 2 diabetes BMI>35

Exclusion Criteria:

  • under 18 years
  • open surgery
  • pregnancy
  • BMI >27-<35
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708083

Locations
Sweden
Ersta hospital
Stockholm, Stockholm County Council, Sweden, 116 91
Karolinska Institutet, CMM
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Anders Thorell, Ass. prof. Karolinska Institutet
  More Information

No publications provided

Responsible Party: Anders Thorell, Associated professor, MD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01708083     History of Changes
Other Study ID Numbers: 2009/1629-31/3
Study First Received: October 9, 2012
Last Updated: August 21, 2013
Health Authority: Sweden: The National Board of Health and Welfare

ClinicalTrials.gov processed this record on April 17, 2014