Clinical trial NCT05896358: Dietary Treatment for Post Bariatric Weight Regain
Official title: Dietary Treatment for Post Bariatric Weight Regain:Evaluation of the Efficacy of a KD
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: weight change
timeFrame: at baseline and right after the dietary intervention (8 weeks)
Secondary outcomes:
measure: body fat change
timeFrame: at baseline and right after the dietary intervention (8 weeks)
measure: muscle mass change
timeFrame: at baseline and right after the dietary intervention (8 weeks)
measure: waist circumference change
timeFrame: at baseline and right after the dietary intervention (8 weeks)
measure: mean blood pressure change
timeFrame: at baseline and right after the dietary intervention (8 weeks)
measure: glucose concentration change
timeFrame: at baseline and right after the dietary intervention (8 weeks)
measure: insulin concentration change
timeFrame: at baseline and right after the dietary intervention (8 weeks)
measure: uric acid concentration change
timeFrame: at baseline and right after the dietary intervention (8 weeks)
measure: creatinine concentration change
timeFrame: at baseline and right after the dietary intervention (8 weeks)
measure: cholesterol concentration change
timeFrame: at baseline and right after the dietary intervention (8 weeks)
measure: triglycerides concentration change
timeFrame: at baseline and right after the dietary intervention (8 weeks)
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Sapienza University of Rome
Study officials:
affiliation: sapienza università di roma
name: lucio gnessi
role: PRINCIPAL_INVESTIGATOR
References: