Primary outcomeMean· one year
Hepatic Fat
| Group | Value (percent of liver fat) | Spread |
|---|---|---|
| Pioglitazone and Exenatide | 4.7 | 1.3 |
| Pioglitazone | 6.5 | 1.9 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataEffect Of Exenatide Treatment on Liver Fat Content in Patients With Diabetes
NCTNCT01432405 (opens ClinicalTrials.gov in a new tab)Other idH-21068
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
- Jun 2007
- Primary completion
- Jul 2008
- Completion
- Jun 2009
- First posted
- 13 Sept 2011 (estimated)
- Last update posted
- 12 Apr 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
2007200820092010
- Ph 4
Effect Of Exenatide Treatment on Liver Fat Content in Patients With Diabetes
NCT01432405Jun 2007 to Jun 2009
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, an anti-diabetes medication, on liver fat and blood levels of proteins that influence liver fat.
Interventions
- ExenatideDrug
- PioglitazoneDrug
Arms2
Experimental
Pioglitazone and exenatide
Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months.
Experimental
Pioglitazone
Pioglitazone 45 mg daily orally for 12 months
Primary outcomes1
Outcomes the sponsor listed as primary.
Hepatic Fat
Time frame · one year
Registry description
The effect of exenatide and pioglitazone on liver fat content after one year of treatment in patients with type 2 diabetes.
Secondary outcomes(1)
Plasma Adipocytokines
Time frame · one year
Registry description
the effect of the intervention on plasma adiponectin levels.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(1)
Secondary outcomeMean· one year
Plasma Adipocytokines
| Group | Value (microgram per ml) | Spread |
|---|---|---|
| Pioglitazone and Exenatide | 23.2 | 2.7 |
| Pioglitazone | 15.8 | 1.4 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Pioglitazone and ExenatideExenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Pioglitazone and exenatide: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus 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. | – | 0 / 12 | 0 / 12 |
| PioglitazonePioglitazone 45 mg daily orally for 12 months Pioglitazone: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus 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. | – | 0 / 12 | 0 / 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
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2011
11 results
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.
Samson et al. 2011Diabetologiacited by 88
PMID 21956711PMC3658171DOI 10.1007/s00125-011-2317-zPUB-21956711
Rights unknown11 results
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 range in age from 30 to 70 years.
2. Patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
3. 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.
4. Patients must meet the American Diabetes Association Criteria for diagnosis of type 2 diabetes mellitus.
5. 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.
6. Patients must have Hematocrit greater than 34%.
7. Subjects whose body weight has been stable (±1 Kg) over the three months prior to study will be included.
Exclusion Criteria:
1, Type 1 diabetes.
2\. 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 (CHF), or clinically significant cardiac, liver or kidney disease (creatinine greater than 1.8 mg/dl).
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