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A Prospective, Randomized Trial to Compare saroGLitazar With pioglitAZone in Nonalcoholic Fatty livEr Disease (GLAZED)

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ClinicalTrials.gov Identifier: NCT02265276
Recruitment Status : Unknown
Verified October 2014 by Hari Kumar, Command Hospital, India.
Recruitment status was:  Recruiting
First Posted : October 15, 2014
Last Update Posted : October 16, 2014
Sponsor:
Information provided by (Responsible Party):
Hari Kumar, Command Hospital, India

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.

Condition or disease Intervention/treatment Phase
Fatty Liver Drug: Saroglitazar Drug: Pioglitazone Phase 3

Detailed Description:
The therapeutic options for the management of nonalcoholic fatty liver disease (NAFLD) include lifestyle modifications, insulin sensitizers, vitamin E, antioxidants and cytoprotective agents. Glitazones are insulin sensitizing drugs and act by stimulating the PPAR gamma receptors. The drugs like Pioglitazone and Rosiglitazone have shown conflicting results in the NAFLD trials. Dual PPAR stimulators (PPAR gamma and PPAR alfa) are known as the "Glitazars" and are useful in simultaneously controlling the hyperglycemia, dyslipidemia and insulin resistance. Saroglitazar is the first drug approved in the investigators country for the management of diabetic dyslipidemia. The investigators plan to study the efficacy of this drug in comparison to Pioglitazone in patients of NAFLD over a period of 24 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Trial to Compare saroGLitazar With pioglitAZone in Nonalcoholic Fatty livEr Disease (GLAZED Trial)
Study Start Date : October 2014
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2015


Arm Intervention/treatment
Active Comparator: Saroglitazar Group
Tab Saroglitazar 4 mg oral daily fixed dose for 24 weeks
Drug: Saroglitazar
Tab Saroglitazar 4 mg oral daily for 24 weeks
Other Name: Glitazar group

Placebo Comparator: Pioglitazone Group
Tab Pioglitazone 30 mg daily fixed dose for 24 weeks
Drug: Pioglitazone
Tab Pioglitazone 30 mg oral daily for 24 weeks
Other Name: Placebo Comparator group




Primary Outcome Measures :
  1. Change in the NAFLD fibrosis score [ Time Frame: At baseline and the end of 24 weeks ]

Secondary Outcome Measures :
  1. Change in body composition [ Time Frame: At baseline and the end of 24 weeks ]
  2. Change in insulin resistance [ Time Frame: At baseline and the end of 24 weeks ]
  3. Change in lipid profile [ Time Frame: At baseline and the end of 24 weeks ]
  4. Change in HbA1c [ Time Frame: At baseline and the end of 24 weeks ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02265276


Contacts
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Contact: Hari Kumar, MD 00918146141700 hariendo@rediffmail.com

Locations
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India
Command Hospital Recruiting
Panchkula, Haryana, India, 134107
Contact: JBS Yadava    00911722867534    hariendo@gmail.com   
Sponsors and Collaborators
Command Hospital, India
Investigators
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Principal Investigator: Hari Kumar, MD Command Hospital

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Responsible Party: Hari Kumar, Endocrinologist, Command Hospital, India
ClinicalTrials.gov Identifier: NCT02265276     History of Changes
Other Study ID Numbers: ENDO/2014/4
First Posted: October 15, 2014    Key Record Dates
Last Update Posted: October 16, 2014
Last Verified: October 2014
Keywords provided by Hari Kumar, Command Hospital, India:
NAFLD, Diabetes, Glitazone
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs