Effect Of Exenatide Treatment on Liver Fat Content in Patients With Diabetes

NCT01432405 | Completed Phase 4 Results

• 1 other identifier: H-21068
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effect of exenatide, an anti-diabetes medication, on liver fat and blood levels of proteins that influence liver fat.

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes

Outcome Measures

Primary Outcomes (1)

• Hepatic Fat

  The effect of exenatide and pioglitazone on liver fat content after one year of treatment in patients with type 2 diabetes.

  one year

Secondary Outcomes (1)

• Plasma Adipocytokines

  one year

Study Arms (2)

Pioglitazone and exenatide

EXPERIMENTAL

Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months.

Drug: Exenatide; Drug: Pioglitazone

Pioglitazone

EXPERIMENTAL

Pioglitazone 45 mg daily orally for 12 months

Drug: Pioglitazone

Interventions

Exenatide DRUG

Type 2 diabetic subjects will be randomized to receive exenatide 10 micrograms injected subcutaneously twice daily for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period.

Also known as: Byetta

Pioglitazone and exenatide

Pioglitazone DRUG

Type 2 diabetic subjects will be randomized to receive pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period.

Also known as: Actos

Pioglitazone; Pioglitazone and exenatide

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must range in age from 30 to 70 years.
• Patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
• Patients may be of either sex. Female patients must be non-lactating and must either be at least two years post-menopausal, or be using adequate contraceptive precautions or be surgically sterilized.
• Patients must meet the American Diabetes Association Criteria for diagnosis of type 2 diabetes mellitus.
• Patients must be on diet therapy alone and/or metformin treatment (stable dose) and have a fasting plasma glucose concentration between 126 and 260 mg/dl.
• Patients must have Hematocrit greater than 34%.
• Subjects whose body weight has been stable (±1 Kg) over the three months prior to study will be included.

You may not qualify if:

• , Type 1 diabetes.
• \. Fasting plasma glucose greater than 260 mg/dl.
• \. Patients must not have received a thiazolidinedione for at least 3 months prior to randomization.
• \. Patients must not be on insulin treatment or have received insulin for more than one week within the previous year prior to entry. Patients should not be on sulfonylureas, sitagliptin, or exenatide treatment.
• \. Patients taking systemic glucocorticoids or other medications known to affect glucose tolerance are excluded.
• \. Patients taking medications that affect gastrointestinal motility will be excluded
• \. Patients with a history of Congestive Heart failure (CHF), or clinically significant cardiac, liver or kidney disease (creatinine greater than 1.8 mg/dl).

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Samson SL, Sathyanarayana P, Jogi M, Gonzalez EV, Gutierrez A, Krishnamurthy R, Muthupillai R, Chan L, Bajaj M. Exenatide decreases hepatic fibroblast growth factor 21 resistance in non-alcoholic fatty liver disease in a mouse model of obesity and in a randomised controlled trial. Diabetologia. 2011 Dec;54(12):3093-100. doi: 10.1007/s00125-011-2317-z. Epub 2011 Sep 29.

  PMID: 21956711 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Exenatide; Pioglitazone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Mandeep Bajaj
• Organization: Baylor College of Medicine

bajaj@bcm.edu

713-798-1712

Study Officials

• Mandeep Bajaj, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 9, 2011
• First Posted: September 13, 2011
• Study Start: June 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: June 1, 2009
• Last Updated: April 12, 2016
• Results First Posted: April 12, 2016

Record last verified: 2016-03

Locations

US (1)