Obesity Clinical Trial
Official title:
Clinical Protocol to Investigate the Efficacy of Amlexanox vs. Placebo for Treatment of Glucose and Lipid Abnormalities in Obese Type 2 Diabetics
Verified date | October 2018 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study involves research about an investigational medicine called Amlexanox. The reason for this study is to find out how Amlexanox can improve type 2 diabetes, insulin resistance, obesity and non-alcoholic fatty liver disease (NAFLD). In this study, Amlexanox is considered to be investigational (not approved by the Food and Drug Administration [FDA]) for type 2 diabetes, insulin resistance, obesity and non-alcoholic fatty liver disease (NAFLD). This is a placebo controlled study. There is a 50-50 chance that the patient may either receive the study drug, Amlexanox, or a placebo (sugar pill). Neither the patient or the study doctors will know if the patient is receiving the study drug or placebo.
Status | Completed |
Enrollment | 42 |
Est. completion date | August 18, 2017 |
Est. primary completion date | April 25, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - = 18 years old at baseline. - Is male, female not of childbearing potential, or meets all the following criteria if female of childbearing potential (including perimenopausal women who have had a menstrual period within one year): - Not breastfeeding. - Negative pregnancy test result (human chorionic gonadotropin, beta subunit [ßhCG]) at baseline (not applicable to hysterectomized females). - Must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate when use consistently and correctly, such as implants, injectables, oral contraceptives, some intrauterine contraceptive devices, sexual abstinence, tubal ligation, or a vasectomized partner) during the entire duration of study period. - Has physician-confirmed diabetes mellitus with a clear diagnosis or per ADA criteria with fasting glucose>126 mg/dL or HbA1c >6.4% or 2 hour GTT >200 mg/dL. - BMI =27 and <45 kg/m2. - On no medications or only on first line oral medications (such as Metformin and/or DPP IV inhibitors) for treatment of Type 2 diabetes mellitus with a stable regimen for >12 weeks. - Alcohol consumption of less than 40 grams/week. - A liver US confirming presence of fatty infiltration of the liver. - Is able to read, understand and sign the U of M IRBMED approved informed consent form (ICF), communicate with study physician and study team, understand and comply with protocol requirements. Exclusion Criteria: - On insulin, or other injectables for treatment of Type 2 diabetes. - Unable to conduct home based glucose monitoring. - HbA1c <6.5% and >10.0% (set to achieve uniformity in the study population). - Presence of advanced liver disease (as evidenced by abnormal synthetic function, abnormal PT or albumin). - Evidence of other etiologies of viral hepatitis. - Presence of hematologic, bone marrow and/or other abnormalities. - Presence of hemoglobinopathy or other hematological abnormalities that will interfere with accurate measurement of HbA1c. - Presence of HIV infection. - Inability to give informed consent. - Presence of ESRD, any type of active cancer, or >class 2 congestive heart failure ((New York Heart Association Functional Classification System), based on medical history and physical examination. - Active chronic infection such as known chronic osteomyelitis or tb, etc. (may be transient). - Creatinine >1.5 mg/dL. - Proliferative diabetic retinopathy, nonproliferative retinopathy is allowed. - Unable to ambulate. - Clinically relevant CAD: history of stent, CABG or cardiologist confirmed angina. - Any other condition in the opinion of the investigators that may impede successful data collection. |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in Hemoglobin A1c Values | Difference in hemoglobin A1c as measured at baseline and week 12 visits | 12 weeks (measured at baseline and 12 weeks) | |
Secondary | Hepatic Steatosis as Measured by MRI | Improvement in hepatic steatosis by MRI is shown by a decrease in percent fat from baseline to week 12 visit. | 12 weeks | |
Secondary | Change in Weight | Change in weight (kilograms) as measured at baseline and week 12 visits. | 12 week |
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