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Effect of Exenatide on Liver and Heart Fat and Inflammation

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ClinicalTrials.gov Identifier: NCT01951651
Recruitment Status : Completed
First Posted : September 26, 2013
Results First Posted : April 15, 2016
Last Update Posted : May 16, 2016
Sponsor:
Information provided by (Responsible Party):
Mandeep Bajaj, Baylor College of Medicine

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Exenatide Drug: Glipizide Phase 4

Detailed Description:
Type 2 diabetics and insulin resistant individuals have an excess of fat in the liver which is not attributable to alcohol or other known causes of liver disease, a condition defined as nonalcoholic fatty liver disease (NAFLD). The fatty liver is insulin resistant. Individuals with a fatty liver are more likely to have excess intra-abdominal fat as well as a reduction in circulating plasma adiponectin levels. We have previously shown that type 2 diabetes and its associated Non Alcoholic Fatty Liver Disease (NAFLD) is characterized by increased hepatic fat content, decreased circulating adiponectin levels, and hepatic and peripheral (muscle) insulin resistance. Weight loss in humans with Non Alcoholic Fatty Liver Disease is associated with a decrease in hepatic fat content. Exenatide, an incretin based anti-diabetes therapy, enhances glucose-dependent insulin secretion and glucose-dependent suppression of inappropriately high glucagon secretion, improves glycemic control in patients with type 2 diabetes and is associated with weight loss. In rodent studies, exenatide reduces hepatic and myocardial fat and reduces vascular inflammation independent of changes in weight. Exenatide has also been shown to increase plasma adiponectin levels in humans and rodents. Furthermore type 2 diabetics are characterized by an increase in both hepatic and myocardial fat and left ventricular dysfunction, particularly diastolic dysfunction. However, the effect of exenatide therapy on liver and myocardial fat content, as well as left ventricular function in patients with type 2 diabetes has not been previously studied.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Exenatide Treatment on Myocardial Fat Content, Left Ventricular Function, and Vascular Inflammation in Patients With Type 2 Diabetes Mellitus
Study Start Date : April 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exenatide
Exenatide 10 micrograms injected subcutaneously twice daily for 6 months
Drug: Exenatide
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.
Other Name: Byetta

Experimental: Glipizide
Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months
Drug: Glipizide
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.
Other Name: Glucotrol




Primary Outcome Measures :
  1. Myocardial Fat Content [ Time Frame: 6 months ]
    Myocardial fat content following intervention as measured by magnetic resonance imaging and spectroscopy (MRS) in patients with type 2 diabetes.

  2. Hepatic Fat Content [ Time Frame: 6 months ]
    Hepatic fat content following intervention in patients with type 2 diabetes


Secondary Outcome Measures :
  1. Left Ventricular Ejection Fraction (LVEF)(%). [ Time Frame: 6 months ]
    Left Ventricular Ejection Fraction following intervention as measured by magnetic resonance imaging in patients with type 2 diabetes.

  2. Monocyte Inflammatory Protein Nuclear Factor Kappa-B (NFkappaB) (%) [ Time Frame: 6 months ]
    The percentage change in monocyte inflammatory proteins NFkappaB (%) from baseline.



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
  2. 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.
  3. Patients must range in age from 30 to 70 years, inclusive.
  4. 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.
  5. 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
  6. Patients must have Hematocrit greater than 34 vol%.
  7. Subjects whose body weight has been stable over the three months prior to study enrollment will be included.

Exclusion Criteria:

  1. Patients must not have type 1 diabetes.
  2. Patients must not have a fasting plasma glucose greater than 260 mg/dl.
  3. Patients must not have received a thiazolidinedione for at least 3 months prior to randomization.
  4. 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.
  5. Patients taking systemic glucocorticoids or other medications known to affect glucose tolerance are excluded.
  6. Patients taking medications that affect gastrointestinal motility will be excluded.
  7. Patients with a history of Congestive Heart Failure, or clinically significant cardiac, liver or kidney disease (creatinine greater than 1.5 mg/dl).

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): NCT01951651


Locations
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United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Mandeep Bajaj, MD Baylor College of Medicine

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Responsible Party: Mandeep Bajaj, Professor of Medicine, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01951651    
Other Study ID Numbers: H-26030
First Posted: September 26, 2013    Key Record Dates
Results First Posted: April 15, 2016
Last Update Posted: May 16, 2016
Last Verified: April 2016
Keywords provided by Mandeep Bajaj, Baylor College of Medicine:
Diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Inflammation
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Exenatide
Glipizide
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists