NCT03534310

Brief Summary

Background/Objectives: Only 1% of the clinically eligible subjects receive surgical treatment for their obesity, thus other options should be investigated. In this study we aim to assess the effect of intensive-lifestyle-modification(ILM) with or without Liraglutide-3mg daily versus sleeve-gastrectomy(SG) on BMI at 1-year. Subjects/Methods: In this study performed in a University Hospital in Italy, non-diabetic patients eligible for bariatric-surgery are recruited from the weight loss clinic and have the option to choose within three possible weight-loss programs up to complete the allocation of 25 subjects in each arm matched by BMI and age. ILM consists in 600kcal very-low-calorie-diet(VLCD) for 1 month followed by 12kcal/kgbw high-protein, high-fat-diet for 11 months plus 30minutes brisk-walk daily and at least 3 hours aerobic-exercise weekly. SG patients have 1-month VLCD and free-diet thereafter. Patients are evaluated at baseline and at 1,3,6,9 and 12months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 2, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2017

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
Last Updated

May 23, 2018

Status Verified

May 1, 2018

Enrollment Period

1.2 years

First QC Date

October 30, 2017

Last Update Submit

May 22, 2018

Conditions

Obesity

Keywords

obesitysleeve-gastrectomyliraglutideWeight-loss

Outcome Measures

Primary Outcomes (1)

  • Change of baseline BMI

    percent variation of BMI with respect to baseline value

    1 year

Secondary Outcomes (6)

  • changes of baseline weight plasma

    1 year

  • changes in body composition

    1 year

  • changes in plasma glucose

    1 year

  • changes in HOMA-IR

    1 year

  • changes in blood pressure

    1 year

  • +1 more secondary outcomes

Study Arms (3)

Lifestyle modification

ACTIVE COMPARATOR

1 month of a VLCD with 865 kcal per day followed by a 12 kcal per kg of body weight of a high-protein, high fat diet for 11 months in association with intensive

Other: lifestyle modification

Lifestyle modification plus Liraglutide 3 mg

EXPERIMENTAL

1 month of a VLCD with 865 kcal per day followed by a 12 kcal per kg of body weight of a high-protein, high fat diet for 11 months in association with intensive. The patients will also receive Liraglutide 3 mg daily sc.

Drug: LIRAGLUTIDE 3 Mg/0.5 mL (18 Mg/3 mL) SUB-Q PEN INJECTOR (ML)Other: lifestyle modification

Sleeve Gastrectomy

ACTIVE COMPARATOR

The patients will undergo laparoscopic sleeve gastrectomy

Other: sleeve gastrectomy

Interventions

LIRAGLUTIDE 3 Mg/0.5 mL (18 Mg/3 mL) SUB-Q PEN INJECTOR (ML)DRUG
Lifestyle modification plus Liraglutide 3 mg
lifestyle modificationOTHER
Lifestyle modificationLifestyle modification plus Liraglutide 3 mg
sleeve gastrectomyOTHER
Sleeve Gastrectomy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ranging from 18 to 70 years, stable body weight in the previous 6 months body mass index (BMI expressed in kg/m2) \>35 if comorbidity (hypertension, sleep apnea, severe hip or knee arthritis) are present or \>40 kg/m2.

You may not qualify if:

  • Type 1 or 2 diabetes, previous bariatric surgery, a history of pancreatitis, a history of major depressive or other severe psychiatric disorders, a family or personal history of multiple endocrine cancer type 2 or familial medullary thyroid carcinoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University School of Medicine

Rome, 00168, Italy

Location

MeSH Terms

Conditions

ObesityWeight Loss

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: lifestyle modification alone, lifestyle modification and Liraglutide 3 mg daily, sleeve gastrectomy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 30, 2017

First Posted

May 23, 2018

Study Start

November 2, 2015

Primary Completion

January 31, 2017

Study Completion

April 10, 2017

Last Updated

May 23, 2018

Record last verified: 2018-05

Locations

IT(1)