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Trial · Interventional

CompletedPhase 4Results postedRegistry data

Effect of Exenatide on Liver and Heart Fat and Inflammation

NCTNCT01951651 (opens ClinicalTrials.gov in a new tab)Other idH-26030
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
24 participants (actual)
Sponsor
Baylor College of Medicine · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Apr 2010
Primary completion
Oct 2012
Completion
Mar 2013
First posted
26 Sept 2013 (estimated)
Last update posted
16 May 2016 (estimated)
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20102011201220132014
  1. Ph 4

    Effect of Exenatide on Liver and Heart Fat and Inflammation

    NCT01951651

    Apr 2010 to Mar 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • ExenatideDrug
  • GlipizideDrug

Arms2

  • Experimental

    Exenatide

    Exenatide 10 micrograms injected subcutaneously twice daily for 6 months

  • Experimental

    Glipizide

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

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Myocardial Fat Content

    Time frame · 6 months

    Registry description

    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

    Registry description

    Hepatic fat content following intervention in patients with type 2 diabetes

Secondary outcomes(2)

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

    Time frame · 6 months

    Registry description

    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

    Registry description

    The percentage change in monocyte inflammatory proteins NFkappaB (%) from baseline.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 6 months

Myocardial Fat Content

GroupValue (percentage of myocardium content)Spread
Exenatide1.70.4
Glipizide1.10.2
Primary outcomeMean· 6 months

Hepatic Fat Content

GroupValue (percent of hepatic fat)Spread
Exenatide10.91.8
Glipizide13.13.5
Secondary and other outcome results(2)
Secondary outcomeMean· 6 months

Left Ventricular Ejection Fraction (LVEF)(%).

GroupValue (percent of Left ventricular function)Spread
Exenatide605
Glipizide562
Secondary outcomeMean· 6 months

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

GroupValue (percentage change from baseline)Spread
Exenatide-65.08.0
Glipizide0.03.0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
ExenatideExenatide 10 micrograms injected subcutaneously twice daily for 6 months 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.–0 / 120 / 12
GlipizideGlipizide 5 mg (tablet), one tablet twice daily orally for 6 months 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.–0 / 120 / 12

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 30 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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).

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