Dietary Treatment for Post Bariatric Weight Regain (WRKD)

Dietary Treatment for Post Bariatric Weight Regain:Evaluation of the Efficacy of a KD

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity
• Intervention / Treatment: Behavioral: ketogenic diet

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00161
    • Sapienza University of Rome

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Pre bariatric treatment arm will be composed of:

-individuals with no history of bariatric surgery

Post bariatric treatment arm will be composed of:

• individuals with previous metabolic surgery (RYGB or Sleeve gastrectomy) and
• excess WL < 50% at 18 months after surgery (IWL) or
• clinically relevant WR after satisfactory WL

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bariatric naive; patients with obesity who have not undergone bariatric surgery in the past	Behavioral: ketogenic diet; a low calorie ketogenic diet
Post Bariatric; patients with obesity who have undergone bariatric surgery in the past and have experienced weight regain or insufficient weight loss	Behavioral: ketogenic diet; a low calorie ketogenic diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight change	body mass change (kg) within and between groups	at baseline and right after the dietary intervention (8 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body fat change	body fat change (kg) within and between groups	at baseline and right after the dietary intervention (8 weeks)
muscle mass change	lean mass change (kg) within and between groups	at baseline and right after the dietary intervention (8 weeks)
waist circumference change	waist circumference change (cm) within and between groups	at baseline and right after the dietary intervention (8 weeks)
mean blood pressure change	mean blood pressure change (mmHg) within and between groups	at baseline and right after the dietary intervention (8 weeks)
glucose concentration change	glucose change (mg/dL) within and between groups	at baseline and right after the dietary intervention (8 weeks)
insulin concentration change	insulin change (UI/mL) within and between groups	at baseline and right after the dietary intervention (8 weeks)
uric acid concentration change	uric acid change (mg/dL) within and between groups	at baseline and right after the dietary intervention (8 weeks)
creatinine concentration change	creatinine change (mg/dL) within and between groups	at baseline and right after the dietary intervention (8 weeks)
cholesterol concentration change	cholesterol change (mg/dL) within and between groups	at baseline and right after the dietary intervention (8 weeks)
triglycerides concentration change	triglycerides change (mg/dL) within and between groups	at baseline and right after the dietary intervention (8 weeks)

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza
• Investigators: Principal Investigator: lucio gnessi, Sapienza Università di Roma

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): June 30, 2023
• Study Completion (Estimated): January 30, 2024

Study Registration Dates

• First Submitted: May 12, 2023
• First Submitted That Met QC Criteria: May 29, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2023KDWR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No