NCT01708083

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 16, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

August 22, 2013

Status Verified

August 1, 2013

Enrollment Period

3.1 years

First QC Date

October 9, 2012

Last Update Submit

August 21, 2013

Conditions

Outcome Measures

Primary Outcomes (2)

  • Differences in polymorphids and/or mRNA expression in genes, significant for developing obesity and type 2 diabetes, between patients with normal weight and obesity

    fat biopsy taken from abdomen, omenta and thigh at surgery

    approximatly 30 minutes after start of operation

  • 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

    fat biopsy; abdomen, omenta and thigh taken at surgery

    approximatly 30 minutes after start of operation

Study Arms (3)

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 Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • under 18 years
  • open surgery
  • pregnancy
  • BMI \>27-\<35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ersta hospital

Stockholm, Stockholm County Council, 116 91, Sweden

Location

Karolinska Institutet, CMM

Stockholm, 171 76, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

biopsys; Fat from oment, thigh and abdomen

Study Officials

  • Anders Thorell, Ass. prof.

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor, MD

Study Record Dates

First Submitted

October 9, 2012

First Posted

October 16, 2012

Study Start

January 1, 2010

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

August 22, 2013

Record last verified: 2013-08

Locations