Clinical trial NCT01785134: Effects of Different Surgical Methods to Treat Obesity
Official title: Metabolic Effects of Different Surgical Methods to Treat Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Type 2 Diabetes
Insulin Sensitivity
Keywords: Obesity
Bariatric Surgery
Insulin Sensitivity
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
name: The Swedish Research Council
First posted: 2013-02-07
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obese patients have an increased risk for developing severe metabolic disorders. This risk can only partly be reduced by weight reduction. The investigators have in a pilot study investigated if removal of abdominal fat (visceral) in addition to weight loss has additional beneficial effects on the metabolic profile and weight loss. This study aims to further investigate if removal of abdominal fat (major omentum) leads to beneficial metabolic effects.


Eligibility criteria: Inclusion Criteria:

Body mass index over 40 kg/m2

Body mass index over 35 kg/m2 with obesity associated co-morbidities such as type 2 diabetes and/or additional cardiovascular risk factors -

Exclusion Criteria:

-

Primary outcomes:
measure: Insulin Sensitivity at 2 Years
timeFrame: 2 years postoperative
Secondary outcomes:
measure: Body Composition at Two Years
timeFrame: 2 years postoperative
measure: Blood Pressure at 2 Years
timeFrame: 2 years postoperative
measure: Body Mass Index at 2 Years
timeFrame: 2 years postoperative
measure: Blood Lipids
timeFrame: 2 years postoperative
Other outcomes:
Locations:
city: Södertälje
country: Sweden
facility: Södertälje Hospital
state: Stockholm
city: Stockholm
country: Sweden
facility: Ersta Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Huddinge
city: Stockholm
country: Sweden
facility: Danderyds Hospital
Study officials:
affiliation: Karolinska Institutet
name: Erik Näslund, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Peter Arner, MD, PhD
role: STUDY_DIRECTOR
affiliation: Karolinska Institutet
name: Johan Hoffstedt, MD, PhD
role: STUDY_CHAIR
References:
citation: van der Kolk BW, Muniandy M, Kaminska D, Alvarez M, Ko A, Miao Z, Valsesia A, Langin D, Vaittinen M, Paakkonen M, Jokinen R, Kaye S, Heinonen S, Virtanen KA, Andersson DP, Mannisto V, Saris WH, Astrup A, Ryden M, Blaak EE, Pajukanta P, Pihlajamaki J, Pietilainen KH. Differential Mitochondrial Gene Expression in Adipose Tissue Following Weight Loss Induced by Diet or Bariatric Surgery. J Clin Endocrinol Metab. 2021 Apr 23;106(5):1312-1324. doi: 10.1210/clinem/dgab072.
citation: Andersson DP, Thorell A, Lofgren P, Wiren M, Toft E, Qvisth V, Riserus U, Berglund L, Naslund E, Bringman S, Thorne A, Arner P, Hoffstedt J. Omentectomy in addition to gastric bypass surgery and influence on insulin sensitivity: a randomized double blind controlled trial. Clin Nutr. 2014 Dec;33(6):991-6. doi: 10.1016/j.clnu.2014.01.004. Epub 2014 Jan 12.