Dietary Treatment for Post Bariatric Weight Regain

Obesity Clinical Trial

— WRKD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05896358
• Other study ID #: 2023KDWR
• Status: Active, not recruiting
• Start date: March 1, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: June 2023
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: January 30, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• ketogenic diet
a low calorie ketogenic diet

Locations

Country	Name	City	State
Italy	Sapienza University of Rome	Roma

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

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