Effect of Diet Versus Sleeve Gastrectomy and Gastric Bypass on Appetite

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-02

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VLED group

Participants will undergo a 10-week VLED.

Group Type EXPERIMENTAL

VLED group

Intervention Type DIETARY_SUPPLEMENT

10-week weight loss period with total meal replacement, consisting of 750 kcal/day. Measurements will be taken at baseline (before diet start), 10 weeks after intervention start (Wk11), and at 1 year.

Sleeve Gastrectomy group

Participants will undergo standard clinical practice prior to surgery.

Group Type EXPERIMENTAL

VLED group

Intervention Type DIETARY_SUPPLEMENT

10-week weight loss period with total meal replacement, consisting of 750 kcal/day. Measurements will be taken at baseline (before diet start), 10 weeks after intervention start (Wk11), and at 1 year.

Sleeve Gastrectomy group

Intervention Type PROCEDURE

Standard clinical practice with 2-week diet consisting of 750 kcal/day prior to surgery. The pre- and post-surgical diet of this group will be matched with the VLED group in macro- and micronutrient composition. Measurements will be taken at baseline (before diet start), 10 weeks after intervention start (Wk11), and 1 year after surgery (sleeve gastrectomy)

Gatric Bypass group

Participants will undergo standard clinical practice prior to surgery.

Group Type EXPERIMENTAL

VLED group

Intervention Type DIETARY_SUPPLEMENT

10-week weight loss period with total meal replacement, consisting of 750 kcal/day. Measurements will be taken at baseline (before diet start), 10 weeks after intervention start (Wk11), and at 1 year.

Gastric Bypass group

Intervention Type PROCEDURE

Standard clinical practice with 2-week diet consisting of 750 kcal/day prior to surgery. The pre- and post-surgical diet of this group will be matched with the VLED group in macro- and micronutrient composition. Measurements will be taken at baseline (before diet start), 10 weeks after intervention start (Wk11), and 1 year after surgery (gastric bypass)

Interventions

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VLED group

10-week weight loss period with total meal replacement, consisting of 750 kcal/day. Measurements will be taken at baseline (before diet start), 10 weeks after intervention start (Wk11), and at 1 year.

Intervention Type DIETARY_SUPPLEMENT

Sleeve Gastrectomy group

Standard clinical practice with 2-week diet consisting of 750 kcal/day prior to surgery. The pre- and post-surgical diet of this group will be matched with the VLED group in macro- and micronutrient composition. Measurements will be taken at baseline (before diet start), 10 weeks after intervention start (Wk11), and 1 year after surgery (sleeve gastrectomy)

Intervention Type PROCEDURE

Gastric Bypass group

Standard clinical practice with 2-week diet consisting of 750 kcal/day prior to surgery. The pre- and post-surgical diet of this group will be matched with the VLED group in macro- and micronutrient composition. Measurements will be taken at baseline (before diet start), 10 weeks after intervention start (Wk11), and 1 year after surgery (gastric bypass)

Intervention Type PROCEDURE

Other Intervention Names

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very-low-energy-diet

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No