NCT05943899

Brief Summary

This retrospective study will be of 12 months duration where 40 T2DM patients coming to FORTIS C-DOC hospital in OPD with F3 fibrosis will be included in the study. The population will be representative of different socio-economic strata of the society. Clinical and dietary profiles, phenotypic markers (acanthosis nigricans, buffalo hump, skin tags, xanthelasma, double chin, arcus, hirsutism) anthropometric assessments body mass index; biochemical markers like liver function test, HbA1c, prothrombin time/INR, and fibroscan will be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2020

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 4, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 13, 2023

Completed
Last Updated

July 17, 2023

Status Verified

July 1, 2023

Enrollment Period

2.9 years

First QC Date

July 4, 2023

Last Update Submit

July 14, 2023

Conditions

Type2diabetes

Outcome Measures

Primary Outcomes (1)

  • Association between SGLT2i intake and hepatic fibrosis

    T2DM patient with moderate to severe fibrosis given SGLT2i and then again evaluated during follow-up visit.

    12 months

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

T2DM patients visiting Fortis CDOC hospital and diagnosed with Moderate/Severe fibrosis were included.

You may qualify if:

  • Patients with T2DM having F3 fibrosis/Child's A Cirrhosis

You may not qualify if:

  • Type 1 Diabetes
  • Alcohol consumption per day (Men \>20 g and women \>10 g)
  • Patients with Child B or Child C Cirrhosis
  • Known case of HIV infection
  • Congestive heart disease
  • Positive hepatitis B or hepatitis C, secondary causes of fatty liver (eg, consumption of amiodarone and tamoxifen) and congestive hepatopathy.
  • Severe end organ damage or chronic diseases: renal/hepatic failure, any malignancy, major systemic illness etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fortis CDOC Hospital

New Delhi, National Capital Territory of Delhi, 110048, India

Location

Study Officials

  • Anoop Misra, MD

    Fortis CDOC Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

July 4, 2023

First Posted

July 13, 2023

Study Start

February 1, 2020

Primary Completion

December 31, 2022

Study Completion

June 30, 2023

Last Updated

July 17, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)