NEFA (Non Esterified Fatty Acid) , Adipose Factors Behind Insulin Sensitivity

Obesity Clinical Trial

Official title:

The Role of Adipose Tissue in Atherogenic Conditions in Man - Mechanisms and Interventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01727245
• Other study ID #: 2011/1002-31/1
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: December 2019

Study information

• Verified date: February 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We want to asses the role of adipose tissue for metabolic complications to obesity before and after weight loss (surgery).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria obese:

• Bariatric surgery with laparoscopic gastric by-pass

Exclusion Criteria obese:

• diabetes mellitus typ 2 with insulin treatment and/or glitazones

• oral or parenteral steroid treatment

• complicated psychiatric disease

• Warfarin use

Inclusion Criteria non-obese controls:

• BMI under 30

Exclusion Criteria non-obese controls:

• diabetes

• oral or parenteral steroids treatment

• complicated psychiatric disease

• Warfarins use

Related Conditions & MeSH terms

• Non-obese Controls
• Obesity

Intervention

Other:
• Obese
gastric bypass
• Control group
Cholecystectomy and anti-reflux surgery

Locations

Country	Name	City	State
Sweden	Danderyds Hospital	Stockholm
Sweden	Ersta Hospital	Stockholm
Sweden	Karolinska University Hospital	Stockholm

Sponsors (4)

Lead Sponsor	Collaborator
Karolinska Institutet	Danderyd Hospital, Ersta Hospital, Sweden, Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity, adipose tissue function and gene function	Performed with hyperinsulinemic euglycemic clamp before and two years after surgery. Subcutaneous and visceral fat biopsy at the time of surgery.	two years after surgery
Secondary	Body composition	DEXA (Dual-Energy X-ray absorptiometry), before and two years after surgery	two years after surgery
Secondary	Vascular function	Non invasive ultrasound of vascular stiffness, before and two years after surgery	two years after surgery