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Comparison of Gastric Bypass and Sleeve Gastrectomy in Metabolic and Cardiovascular Indices

N

National and Kapodistrian University of Athens

Status

Completed

Conditions

Morbid Obesity

Treatments

Procedure: Bariatric surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT03851874
Bariatric study

Details and patient eligibility

About

Morbidly obese patients undergoing either Roux en Y gastric bypass or sleeve gastrectomy were examined preoperatively, 3, 6, and 12 months after surgery. On each occasion, anthropometric data were collected, resting metabolic rate was measured, and the patients underwent a panel of cardiovascular examinations (heart rate variability, baroreflex sensitivity, heart ultrasound). Following that, they consumed a test meal and completed visual analog scales for the subjective assessment of hunger and fullness every 30 minutes for 3 hours. At the same time points, blood samples were collected for the consequent measurement of glucose, insulin, lipids, and gastrointestinal hormones.

Enrollment

28 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • BMI >40 kg/m2
  • Age between 18 and 65 years
  • Proven failure to lose weight through non-surgical interventions

Exclusion criteria

  • Serious and life threatening comorbidities (renal, cardiac, liver failure, or malignancy)
  • Patients' inability to adhere to postsurgical instructions
  • Alcohol or other substance abuse
  • Concurrent psychiatric illness

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

28 participants in 2 patient groups

Gastric bypass bariatric surgery
Active Comparator group
Description:
Patients in this arm underwent Roux-en-Y gastric bypass bariatric surgery for the treatment of morbid obesity
Treatment:
Procedure: Bariatric surgery
Sleeve gastrectomy bariatric surgery
Active Comparator group
Description:
Patients in this arm underwent sleeve gastrectomy bariatric surgery for the treatment of morbid obesity
Treatment:
Procedure: Bariatric surgery

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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