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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014