Effect of Exenatide on Liver and Heart Fat and Inflammation

NCT01951651 | Completed Phase 4 Results

• 1 other identifier: H-26030
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effect of exenatide on liver and heart (myocardial) fat and inflammation.

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes

Outcome Measures

Primary Outcomes (2)

• Myocardial Fat Content

  Myocardial fat content following intervention as measured by magnetic resonance imaging and spectroscopy (MRS) in patients with type 2 diabetes.

  6 months

• Hepatic Fat Content

  Hepatic fat content following intervention in patients with type 2 diabetes

  6 months

Secondary Outcomes (2)

• Left Ventricular Ejection Fraction (LVEF)(%).

  6 months

• Monocyte Inflammatory Protein Nuclear Factor Kappa-B (NFkappaB) (%)

  6 months

Study Arms (2)

Exenatide

EXPERIMENTAL

Exenatide 10 micrograms injected subcutaneously twice daily for 6 months

Drug: Exenatide

Glipizide

EXPERIMENTAL

Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months

Drug: Glipizide

Interventions

Exenatide DRUG

Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months.

Also known as: Byetta

Exenatide

Glipizide DRUG

Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months.

Also known as: Glucotrol

Glipizide

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 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.
• Patients must range in age from 30 to 70 years, inclusive.
• Patients must meet the American Diabetes Association (ADA) criteria (ADA 1997 Criteria: fasting plasma glucose greater than or equal to 126 mg/dl) for the diagnosis of type 2 diabetes mellitus.
• Patients must be on diet therapy and/or metformin treatment for type 2 diabetes (stable dose)and have a fasting plasma glucose concentration between 126 and 260 mg/dl
• Patients must have Hematocrit greater than 34 vol%.
• Subjects whose body weight has been stable over the three months prior to study enrollment will be included.

You may not qualify if:

• Patients must not have type 1 diabetes.
• Patients must not have a 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, or clinically significant cardiac, liver or kidney disease (creatinine greater than 1.5 mg/dl).

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Exenatide; Glipizide

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; Sulfonylurea Compounds; Sulfones; Sulfur Compounds; Organic Chemicals

Results Point of Contact

• Title: Mandeep Bajaj
• Organization: Baylor

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 of Medicine

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: September 26, 2013
• Study Start: April 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: March 1, 2013
• Last Updated: May 16, 2016
• Results First Posted: April 15, 2016

Record last verified: 2016-04

Locations

US (1)