NCT02417103

Brief Summary

The aim of this study is to investigate the effect of the treatment with the GLP-1 Analogon Liraglutide on the lipid metabolism an inflammation in adipose tissue.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_3 obesity

Timeline
Completed

Started Dec 2011

Longer than P75 for phase_3 obesity

Geographic Reach
1 country

1 active site

Status
terminated

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

December 1, 2011

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

4.8 years

First QC Date

April 10, 2015

Last Update Submit

June 29, 2022

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • weight reduction

    to compare body weight with type 2 Diabetes scheduled for weight loss surgery after 8 weeks of preoperative treatment with either placebo or liragludite

    4 years

Secondary Outcomes (1)

  • GLP-1 Levels

    4 years

Study Arms (2)

GLP-1 (Liraglutide)

ACTIVE COMPARATOR

Daily subcutaneous injection of Lirglutide over 9 weeks prior to bariatric surgery with a dosing of 0,6-1,8 mg

Drug: GLP-1 (Liraglutide)

Placebo Comparator

PLACEBO COMPARATOR

Daily subcutaneous injection of PL1/PR1 Placebo over 9 weeks prior to bariatric surgery with a dosing of 0,6-1,8 mg

Drug: Placebo

Interventions

GLP-1 (Liraglutide)DRUG

GLP-1 Analogon

Also known as: Victoza
GLP-1 (Liraglutide)
PlaceboDRUG

Placebo

Also known as: PL1 PR1
Placebo Comparator

Eligibility Criteria

Age18 Years - 77 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 35-55 Kg/m2
  • Fasting Blood glucose \>140mg/dl
  • Planned bariatric surgery
  • Diabetic Medication (Metformin, Sulfonylurea, Insuline)

You may not qualify if:

  • Known hypersensitivity against Liraglutid
  • Pretreatment DPP-4 Inhibitors or GLP-1 Analogue the last 3 months
  • HbA1c \>10%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Hamburg

Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Obesity

Interventions

Glucagon-Like Peptide 1Liraglutide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Jens Aberle, MD

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2015

First Posted

April 15, 2015

Study Start

December 1, 2011

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

June 30, 2022

Record last verified: 2022-06

Locations

DE(1)