ClinicalTrials.Veeva

Menu

Dietary Treatment for Post Bariatric Weight Regain (WRKD)

U

University of Roma La Sapienza

Status

Active, not recruiting

Conditions

Obesity

Treatments

Behavioral: ketogenic diet

Study type

Observational

Funder types

Other

Identifiers

NCT05896358
2023KDWR

Details and patient eligibility

About

Metabolic surgery has, among all obesity treatments, the best long term efficacy, but weight regain (weight regain, WR) or insufficient weight loss (IWL) are relatively common. These are hard to treat, with dietary treatment often failing, and redo surgery being commonly proposed.The ketogenic diet is vastly utilised to obtain weight loss in obesity, but little data is available regarding its application on post bariatric patients. Ad hoc designed studies are needed to confirm the efficacy and safety of a VLCKD in the treatment of WR and IWL. The aim of this study is to test whether the ketogenic diet is a safe and effective treatment in post bariatric weight regain, compared to its application before bariatric surgery.

Full description

Metabolic surgery is, to date, the strategy for the treatment of obesity with the greatest long-term efficacy. However, especially in those lost to surgical and nutritional follow-up, weight regain (weight regain, WR) or insufficient weight loss (IWL) are relatively common. In particular, depending on the type of surgery considered, it has been observed that up to 40% of subjects undergoing surgery report a WR long term, where data on IWL are still insufficient to draw well-defined estimates. WR and IWL are hard to treat, with dietary treatment often failing, and redo surgery being commonly proposed, with increased risk of complications and little effect.

The ketogenic diet is one of the pivotal dietary therapies for the treatment of obesity, with excellent evidence in terms of weight loss and improvement in complications of excess weight. Very little data is available regarding its application on post bariatric patients: Correa and colleagues reported in a retrospective case series the efficacy and safety of a very low calorie ketogenic diet (VLCKD) in 11 patients with IWL or WR after gastric bypass, reporting a good safety profile, good tolerability, and an average weight loss of 9 kg in 2 months of therapy. Although promising, the data in the literature are extremely scarce, and therefore ad hoc designed studies are needed to confirm the efficacy and safety of a VLCKD in the treatment of WR and IWL.

The objective of this study is to test whether the application of a ketogenic diet is a safe and effective treatment in post bariatric weight regain, compared to its application before bariatric surgery.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

-obesity (BMI ≥ 30 Kg/m2)

Exclusion criteria

  • Type 1 diabetes mellitus
  • Renal failure (GFR<60)
  • Liver failure (decompensated cirrhosis)
  • Congenital metabolic diseases
  • Pregnancy
  • lactation
  • Major psychiatric disorder
  • Alcoholism
  • drug addiction
  • patients who are not self-sufficient and without adequate family and social support

Trial design

30 participants in 2 patient groups

Bariatric naive
Description:
patients with obesity who have not undergone bariatric surgery in the past
Treatment:
Behavioral: ketogenic diet
Post Bariatric
Description:
patients with obesity who have undergone bariatric surgery in the past and have experienced weight regain or insufficient weight loss
Treatment:
Behavioral: ketogenic diet

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems