Effect of Diet Versus Sleeve Gastrectomy and Gastric Bypass on Appetite (DISGAP)

Norwegian University of Science and Technology

Status: Completed

Conditions: Obesity

Treatments: Procedure: Sleeve Gastrectomy group; Dietary Supplement: VLED group; Procedure: Gastric Bypass group

Study type: Interventional

Funder types: Other

Identifiers

NCT04051190

2019/252

Details and patient eligibility

About

The biggest challenge in obesity management is maintaining weight loss in the long-term. Currently, bariatric surgery is the most effective treatment, leading to sustained weight loss that is not yet achievable with lifestyle intervention (e.g. diet). The reasons behind its success is still not clearly understood, but beneficial changes in the homeostatic and hedonic appetite systems (the two major physiological regulators of appetite), along with the microbiome (known to have a mediatory effect on appetite) have been shown to occur after bariatric surgery. These alterations are in opposition to what is seen after diet-induced weight loss. Today, the component of appetite regulation that drives bariatric surgeys' long-term success is still unknown. By comparing a lifestyle and surgical intervention in parallel, the investigators can observe the impact of a similar magnitude of weight loss on these three domains of appetite regulation simultaneously, thereby illuminating the mechanisms behind bariatric surgerys' success.

Enrollment: 54 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• scheduled for bariatric surgery
• patient in obesity clinic
• Body mass index (BMI) 35-55

Exclusion criteria

• Currently taking medication known to affect energy metabolism or appetite
• Current cancer diagnosis
• Substance abuse
• Enrolled in another obesity treatment
• Eating disorders
• pre-existing endocrine disorders (e.g. diabetes) will not be excluded, but final analysis will controlled for these conditions

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 3 patient groups

VLED group

Experimental group

Description:

Participants will undergo a 10-week VLED.

Treatment:

Dietary Supplement: VLED group

Sleeve Gastrectomy group

Experimental group

Description:

Participants will undergo standard clinical practice prior to surgery.

Treatment:

Dietary Supplement: VLED group

Procedure: Sleeve Gastrectomy group

Gatric Bypass group

Experimental group

Description:

Participants will undergo standard clinical practice prior to surgery.

Treatment:

Dietary Supplement: VLED group

Procedure: Gastric Bypass group