NCT00134303

Brief Summary

This is a comparison of metformin versus placebo in NASH patients receiving bariatric surgery for obesity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for phase_4 obesity

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_4 obesity

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

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2006

Completed
Last Updated

December 8, 2022

Status Verified

December 1, 2022

Enrollment Period

10 months

First QC Date

August 23, 2005

Last Update Submit

December 7, 2022

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Number of patients with histological amelioration of NASH after a period of 1 year

    1 year

Secondary Outcomes (1)

  • Number of patients with normalisation of ALT, steatosis on ultrasound after a period of 1 year

    1 year

Study Arms (1)

NASH

EXPERIMENTAL
Drug: Metformin

Interventions

MetforminDRUG

Metformin is used.

NASH

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients receiving bariatric surgery for obesity

You may not qualify if:

  • Other causes of liver disease (hepatitis B virus \[HBV\], hepatitis C virus \[HCV\], primary biliary cirrhosis \[PBC\], etc.)
  • Patients with diabetes type I
  • Patients with endocrinological reasons for obesity (eg. Cushing, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Conditions

Obesity

Interventions

Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Hans Van Vlierberghe, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2005

First Posted

August 24, 2005

Study Start

June 1, 2005

Primary Completion

March 31, 2006

Study Completion

March 31, 2006

Last Updated

December 8, 2022

Record last verified: 2022-12

Locations

BE(1)