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Completed

NCT Number: NCT01727245

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

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

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Key information

Conditions

Obesity Body Weight Non-obese Controls Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danderyds Hospital, Stockholm, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Obese

Other

gastric bypass

Control Group

Other

Cholecystectomy and anti-reflux surgery

Primary outcomes

  1. Insulin sensitivity, adipose tissue function and gene function

    Time frame: two years after surgery

    Performed with hyperinsulinemic euglycemic clamp before and two years after surgery. Subcutaneous and visceral fat biopsy at the time of surgery.

Secondary outcomes

  1. Body composition

    Time frame: two years after surgery

    DEXA (Dual-Energy X-ray absorptiometry), before and two years after surgery

  2. Vascular function

    Time frame: two years after surgery

    Non invasive ultrasound of vascular stiffness, before and two years after surgery

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Danderyd Hospital
  • Ersta Hospital, Sweden
  • Karolinska University Hospital

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Nov 15, 2012
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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