Trial Outcomes & Findings for Effects of Different Surgical Methods to Treat Obesity (NCT NCT01785134)

NCT ID: NCT01785134

Last Updated: 2014-10-02

Results Overview

Insulin sensitivity measured by hyperinsulinemic euglycemic clamp

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 81 participants
• Primary outcome timeframe: 2 years postoperative
• Results posted on: 2014-10-02

Participant Flow

Participant milestones

Measure	Control Gastric bypass operation without omentectomy. Gastric bypass operation	Omentectomy Gastric bypass operation in conjunction with removal of greater omentum Omentectomy Gastric bypass operation
Overall Study STARTED	41	40
Overall Study COMPLETED	29	33
Overall Study NOT COMPLETED	12	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Different Surgical Methods to Treat Obesity

Baseline characteristics by cohort

Measure	Control n=41 Participants Gastric bypass operation without omentectomy. Gastric bypass operation	Omentectomy n=40 Participants Gastric bypass operation in conjunction with removal of greater omentum Omentectomy Gastric bypass operation	Total n=81 Participants Total of all reporting groups
Age, Continuous	41 years STANDARD_DEVIATION 9 • n=93 Participants	43 years STANDARD_DEVIATION 9 • n=4 Participants	42 years STANDARD_DEVIATION 9 • n=27 Participants
Sex: Female, Male Female	41 Participants n=93 Participants	40 Participants n=4 Participants	81 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment Sweden	41 participants n=93 Participants	40 participants n=4 Participants	81 participants n=27 Participants

PRIMARY outcome

Timeframe: 2 years postoperative

Insulin sensitivity measured by hyperinsulinemic euglycemic clamp

Outcome measures

Measure	Control n=29 Participants Gastric bypass operation without omentectomy. Gastric bypass operation	Omentectomy n=33 Participants Gastric bypass operation in conjunction with removal of greater omentum Omentectomy Gastric bypass operation
Insulin Sensitivity at 2 Years	6.7 glucose/kg body weight/min Standard Deviation 1.6	6.6 glucose/kg body weight/min Standard Deviation 1.5

SECONDARY outcome

Timeframe: 2 years postoperative

Outcome measures

Measure	Control n=29 Participants Gastric bypass operation without omentectomy. Gastric bypass operation	Omentectomy n=33 Participants Gastric bypass operation in conjunction with removal of greater omentum Omentectomy Gastric bypass operation
Body Composition at Two Years	36 % body fat Standard Deviation 8	38 % body fat Standard Deviation 8

SECONDARY outcome

Timeframe: 2 years postoperative

Outcome measures

Measure	Control n=29 Participants Gastric bypass operation without omentectomy. Gastric bypass operation	Omentectomy n=33 Participants Gastric bypass operation in conjunction with removal of greater omentum Omentectomy Gastric bypass operation
Blood Pressure at 2 Years	123 mm Hg systolic Standard Deviation 16	121 mm Hg systolic Standard Deviation 23

SECONDARY outcome

Timeframe: 2 years postoperative

Outcome measures

Measure	Control n=29 Participants Gastric bypass operation without omentectomy. Gastric bypass operation	Omentectomy n=33 Participants Gastric bypass operation in conjunction with removal of greater omentum Omentectomy Gastric bypass operation
Body Mass Index at 2 Years	28.6 Kg/meter squared Standard Deviation 4.6	28.9 Kg/meter squared Standard Deviation 4.3

SECONDARY outcome

Timeframe: 2 years postoperative

Outcome measures

Measure	Control n=29 Participants Gastric bypass operation without omentectomy. Gastric bypass operation	Omentectomy n=33 Participants Gastric bypass operation in conjunction with removal of greater omentum Omentectomy Gastric bypass operation
Blood Lipids	4.0 P-Cholesterol mmol/L Standard Deviation 0.9	4.2 P-Cholesterol mmol/L Standard Deviation 0.8

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Omentectomy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Erik Näslund

Karolinska Institutet

Phone: +46812355017

Email: Erik.Naslund@ki.se

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place