Evaluation of the DPP-4 Inhibitor Sitagliptin in the Treatment of Non-Alcoholic Fatty Liver Disease Using MRI

NCT02263677 | Withdrawn Phase 4

• 1 other identifier: MERCK-9938
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Participants will be persons with type 2 diabetes who are likely to have fatty liver disease. The investigators think that this medication will reduce fatty liver. The investigators will use an MRS (a non invasive method using magnets) to evaluate liver fat before and after subjects take a diabetes medication. The investigators will also collect a small amount of blood to measure liver, kidney and hormone functions. This will be done 4 times. Also, at the time of the subject gets their first dose of medication they will have a DEXA (low exposure x-ray often used in clinical practice to measure bone density and body composition). The goal of all of these studies is to determine whether the study drug lowers liver fat.

Conditions

Type 2 Diabetes; Non-alcoholic Fatty Liver Disease

Keywords

diabetes; fatty liver

Outcome Measures

Primary Outcomes (1)

• Change in Liver steatosis

  Steatosis measured by Magnetic Resonance Spectroscopy

  baseline and Six months

Study Arms (1)

Sitagliptin

EXPERIMENTAL

60 day supply of 100mg Sitagliptin

Drug: Sitagliptin

Interventions

Sitagliptin DRUG

60 day supply of 100mg Sitagliptin. The investigators will use an MRS (a non invasive method using magnets) to evaluate liver fat before and after subjects take a diabetes medication. The investigators will also collect a small amount of blood to measure liver, kidney and hormone functions. This will be done 4 times. Also, at the time of the subject gets their first dose of medication they will have a DEXA (low exposure x-ray often used in clinical practice to measure bone density and body composition).

Also known as: Januvia

Sitagliptin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes mellitus with hemoglobin A1c above 6.5%.
• Waist circumference over 40 inches in a male or 35 inches in a female or BMI greater than 30.
• Age between 18 and 70 years.
• Stable on maximum tolerated dose of metformin for at least 3 months prior to enrollment.
• Sedentary (less than 30 minutes per week of structured activity) and weight stable (2% body weight in past 6 months).
• Metabolic syndrome based on NCEP ATP-3 guidelines with diabetes accepted as the glycemic component.
• For women: at least 2 years postmenopausal, surgically sterile, or using an acceptable contraceptive regimen to include OCP, IUD, double barrier, depo-provera, or subcutaneous progestin implant and negative urine pregnancy test at trial start.
• For men: surgically sterile or agreement that any female partner meet criteria of 7.

You may not qualify if:

• Pregnancy, breast feeding, or planning to become pregnant during the study period.
• GFR less than 60mL per minute per meter squared.
• Any medical condition expected to be terminal within one year.
• Cirrhosis of any cause or liver disease due to auto-immune, infectious or alcohol induced hepatitis.
• Active mental illness or other condition which in the opinion of the investigator would prevent informed consent or compliance with study protocol.
• Use of PPAR agonist within six months prior to enrollment.
• Daily insulin use.
• Allergy or intolerance of sitagliptin or other DPP-4 inhibitor.
• Use of DPP-4 inhibitor, bile acid sequesterant, or weight loss medications within three months prior to enrollment.
• Significant alcohol use defined as greater than 21 standard servings of alcohol (10gms) per week for men and greater than 14 for women.
• History of bariatric surgery or planned bariatric surgery during the study period.
• Weight, girth, or other factor preventing MRI scanning.
• Receipt of another study drug within 30 days of screening.
• Unable to receive a DEXA scan due to participating in research study or medical procedure involving ionizing radiation exposure equivalent to a chest x-ray or greater in the past 12 months.

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri-Columbia: Diabetes Center

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Non-alcoholic Fatty Liver Disease; Diabetes Mellitus; Fatty Liver

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Michael Gardner, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2014
• First Posted: October 13, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: October 5, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)