Gut Hormones as Mediators of Different Weight Loss Responses After Roux-en-Y Gastric Bypass

Hvidovre University Hospital

Status and phase: Unknown; Phase 4

Conditions: Bariatric Surgery (Gastric Bypass); Severe Obesity

Treatments: Other: Sham feeding; Other: Meal tests after octreotide injection; Other: Meal tests after saline injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02374632

KBM-R2-14

Details and patient eligibility

About

After gastric bypass, 10-20% of patients will obtain a suboptimal weight loss, often defined as <50% of the excess body weight. Exaggerated meal related secretion of gut hormones seem important for appetite reduction and subsequent weight loss after gastric bypass, however it is not clear whether different gut hormone responses are responsible for different postoperative weight loss responses. The purpose of the study is to investigate gut hormone secretion, vagal integrity and the effect of octreotide on ad libitum food intake in patients with suboptimal weight loss after gastric bypass and compare results to a matched group of gastric bypass operated patients with high postoperative weight loss but similar age, sex and preoperative BMI.

Enrollment: 40 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Uncomplicated primary Roux-en-Y gastric bypass >12 months ago
• Postoperative weight loss of >60%EBL or <50%EBL.

Exclusion criteria

• Inadequately treated thyroid disease
• Hemoglobin <6.5 mM
• Pregnancy or breastfeeding

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Low EBL

Other group

Description:

Gastric bypass operated patients with low postoperative excess body weight loss (EBL) \<50%. Interventions: Meal tests after saline/octreotide injection in a randomized order, sham feeding.

Treatment:

Other: Sham feeding

Other: Meal tests after octreotide injection

Other: Meal tests after saline injection

High EBL

Other group

Description:

Gastric bypass operated patients with high postoperative excess body weight loss (EBL) \>70% matched with respect to age, gender and preoperative BMI in the LowEBL group. Interventions: Meal tests after saline/octreotide injection in a randomized order, sham feeding.

Treatment:

Other: Sham feeding

Other: Meal tests after octreotide injection

Other: Meal tests after saline injection