Status:
COMPLETED
Uncovering the 'ORIGINS' of Diabetes
Lead Sponsor:
AdventHealth Translational Research Institute
Collaborating Sponsors:
AdventHealth
Sanford-Burnham Medical Research Institute
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Brief Summary
This is a study to identify different subtypes of type 2 diabetes. The investigators will look for information at the molecular level, which may lead to personalized diagnosis and therapies.
Detailed Description
Type 2 diabetes mellitus (T2DM) is approaching epidemic prevalence in the US adult population (over 1 in 10 of all US adults over 20). Diabetes is diagnosed based on fasting hyperglycemia, oral glucos...
Eligibility Criteria
Inclusion
- Age \> 18
- HbA1C \< 8.0% \*
- You have not gained or lost more than 3 kg or 6.6 pounds in the last 8 weeks
- You have not lost more than 10% of your heaviest body weight in your lifetime
- BMI \< 25 kg/m2 or \> 30 kg/m2
- Women: more than 1 year post-partum
- Have diabetes and are able to maintain accurate and reliable home glucose monitoring logs
Exclusion
- Treatment with more than 2 of the following: metformin (Fortamet, Glucophage, Glumetza, Riomet), sulfonylureas (Glucotrol, Diabeta, Glynase, Micronase), Glucagon-like peptide-1 analogs (Byetta) and/or Dipeptidyl peptidase IV inhibitors (Januvia, Onglyza)
- Treatment with long acting Glucagon-like peptide-1 agonists within the last 3 months (i.e. exenatide once weekly)
- Treatment with thiazolidinediones (TZDs) (i.e. Avandia, Actos, Rezulin) within the last 3 months
- Known, untreated thyroid disease or abnormal thyroid function blood test.\*
- Known diagnosis of liver disease (except NASH) or elevated liver function blood test
- Known diagnosis of kidney disease or elevated kidney function blood test
- Uncontrolled high blood pressure (BP \> 140 systolic or \> 90 diastolic)
- Start of or changes in oral contraceptives or hormone replacement therapy within the last 3 months
- Use of drugs or alcohol (\> 3 drinks per day) within the last 5 years.
- Uncontrolled psychiatric disease that would interfere with study participation.
- History of cancer within the last 5 years (skin cancers, with the exception of melanoma, may be acceptable)
- History of organ transplant
- History of heart attack within the last 6 months
- Current treatment with blood thinners or antiplatelet medications that cannot be safely stopped for testing procedures
- Current anemia
- History of HIV, active Hepatitis B or C, or Tuberculosis
- Presence of clinically significant abnormalities on electrocardiogram.
- Current smokers (smoking any nicotine or non-nicotine product within the past 3 months)
- Use of any medications known to influence glucose, fat and/or energy metabolism within the last 3 months (e.g., growth hormone therapy, glucocorticoids \[steroids\], etc.)
Key Trial Info
Start Date :
November 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT02226640
Start Date
November 1 2010
End Date
June 1 2014
Last Update
February 22 2018
Active Locations (1)
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1
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, United States, 32804