NCT04583683

Brief Summary

It is a prospective randomized trial on 218 subjects, 109 for each arms. The purpose of this trial is to compare very low calorie diet and metabolic surgery induced weight loss and its maintenance.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
218

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

September 30, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 12, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2020

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

3 months

First QC Date

September 30, 2020

Last Update Submit

May 23, 2021

Conditions

Obesity, MorbidObesityDiet, HealthyBariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

  • Time to achieve a 25% reduction in Body Mass Index

    1-12 months

Secondary Outcomes (10)

  • Percentage of participants who achieve 25% reduction in Body Mass Index

    1-12 months

  • Time to achieve 25% reduction in Body Mass Index

    1-24months

  • Change in body composition (lean mass-all tissues in the body except bone and fat-fat mass, bone density and visceral fat) using dual energy X-ray absorptiometry (DXA), from baseline, at 25% weight loss, at 12 months follow up and at 24 months follow up

    1-24months

  • Change in glycated hemoglobin (HbA1c), from baseline, at 12 and 24 months follow up (patients with diabetes)

    1-24months

  • Change in fasting glucose and fasting insulin, from baseline, at 12 and 24 months follow up

    1-24months

  • +5 more secondary outcomes

Study Arms (2)

Intensive lifestyle modification: Very low calorie diet

ACTIVE COMPARATOR

Patients will undergo a very low calorie diet

Behavioral: Very low calorie diet with Fortimel (Nutricia) supplementation

Metabolic Surgery

ACTIVE COMPARATOR

Patients will undergo metabolic surgery

Procedure: Metabolic Surgery

Interventions

Very low calorie diet with Fortimel (Nutricia) supplementationBEHAVIORAL

Patients will undergo a very low calorie diet

Intensive lifestyle modification: Very low calorie diet
Metabolic SurgeryPROCEDURE

Patients will undergo metabolic surgery

Metabolic Surgery

Eligibility Criteria

Age19 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 19 and 69 years
  • Body Mass Index ≥35 kg/m2 and at least one or more obesity-related co-morbidities such as type II diabetes (T2DM), hypertension, sleep apnea and other respiratory disorders, non-alcoholic fatty liver disease, osteoarthritis, lipid abnormalities, gastrointestinal disorders, or heart disease
  • Body Mass Index ≥40 kg/m2

You may not qualify if:

  • Pregnancy
  • Active cancer
  • End stage renal failure
  • End stage liver failure
  • Being unable to understand and sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University School of Medicine

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Obesity, MorbidObesity

Interventions

Dietary SupplementsBariatric Surgery

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesBariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 30, 2020

First Posted

October 12, 2020

Study Start

September 30, 2020

Primary Completion

December 28, 2020

Study Completion

September 30, 2022

Last Updated

May 25, 2021

Record last verified: 2021-05

Locations

IT(1)