NCT02265276

Brief Summary

Non Alcoholic Fatty Liver Disease (NAFLD) is considered as the component of metabolic syndrome. The prevalence of the same has been increasing rapidly in India, along with an increase in the prevalence of diabetes and obesity. Insulin resistance is the key underlying pathogenetic mechanism of NAFLD. NAFLD accounts for significant morbidity and mortality and the therapeutic options are limited. Insulin sensitizing drugs are used in the management of NAFLD.

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
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_3

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

Study Start

First participant enrolled

October 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 15, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 16, 2014

Status Verified

October 1, 2014

Enrollment Period

11 months

First QC Date

October 7, 2014

Last Update Submit

October 14, 2014

Conditions

Fatty Liver

Keywords

NAFLD, Diabetes, Glitazone

Outcome Measures

Primary Outcomes (1)

  • Change in the NAFLD fibrosis score

    At baseline and the end of 24 weeks

Secondary Outcomes (4)

  • Change in body composition

    At baseline and the end of 24 weeks

  • Change in insulin resistance

    At baseline and the end of 24 weeks

  • Change in lipid profile

    At baseline and the end of 24 weeks

  • Change in HbA1c

    At baseline and the end of 24 weeks

Study Arms (2)

Saroglitazar Group

ACTIVE COMPARATOR

Tab Saroglitazar 4 mg oral daily fixed dose for 24 weeks

Drug: Saroglitazar

Pioglitazone Group

PLACEBO COMPARATOR

Tab Pioglitazone 30 mg daily fixed dose for 24 weeks

Drug: Pioglitazone

Interventions

SaroglitazarDRUG

Tab Saroglitazar 4 mg oral daily for 24 weeks

Also known as: Glitazar group
Saroglitazar Group
PioglitazoneDRUG

Tab Pioglitazone 30 mg oral daily for 24 weeks

Also known as: Placebo Comparator group
Pioglitazone Group

Eligibility Criteria

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

You may qualify if:

  • Drug naive patients with NAFLD diagnosed on ultrasonography, BMI \> 23 kg/m2 and ALT \> 1.5 times the upper limit of normal

You may not qualify if:

  • Use of any drugs other than lifestyle modification for NAFLD, HbA1c \> 8% FBS\>200, Bilirubin \> 1.5 mg/dL
  • Any illness likely to cause transaminitis and positive viral markers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Command Hospital

Panchkula, Haryana, 134107, India

RECRUITING

MeSH Terms

Conditions

Fatty LiverNon-alcoholic Fatty Liver DiseaseDiabetes Mellitus

Interventions

saroglitazarPioglitazone

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Hari Kumar, MD

    Command Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hari Kumar, MD

CONTACT

00918146141700hariendo@rediffmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Endocrinologist

Study Record Dates

First Submitted

October 7, 2014

First Posted

October 15, 2014

Study Start

October 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

October 16, 2014

Record last verified: 2014-10

Locations

IN(1)