Status:
COMPLETED
Molecular Mechanisms of Type 2 Diabetes Mellitus
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborating Sponsors:
Takeda
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This project is designed to evaluate the molecular mechanisms involved in the early development of endothelial dysfunction in type 2 diabetic patients. The investigators intend to correlate increases ...
Detailed Description
Specific Aims To test the global hypothesis that increases in insulin signaling through either PI-3-kinase or MAP kinase pathways correlate with improvements in NO production or NOS expression in ske...
Eligibility Criteria
Inclusion
- male or female 18-65 years of age;
- type 2 diabetes based on the American Diabetes Association criteria;
- HbA1c = 6.5-9.0% while on diet alone or diet plus sulfonylurea (or meglitinides) therapy;
- no history of thiazolidinediones, insulin, ACE inhibitor or AII-receptor blockade therapy;
- taking no medications known to affect glycemic control or endothelial function, unless the medication has been stable for at least 3 months;
- blood pressure equal or below 140/90 mmHg;
- not pregnant and willing to take appropriate contraceptive measures if capable of becoming pregnant;
- serum creatinine below 1.7 mg/dl in female and 1.8 mg/dl in males;
- ALT (SGTP) or AST (SGOT) less than 2 times the upper limit of normal for the laboratory and absence of clinical signs or symptoms of liver disease;
- hematocrit \> 34% in females and \>35% in males;
- normal thyroid function;
- no evidence of coronary heart disease (by history or EKG) or moderate to severe congestive heart failure (NY Heart Association Cardiac Class III or IV);
- no history or the presence of any clinically significant or unstable medical condition that makes the subject unlikely to complete the study in the opinion of the PI; and
- absence of any condition or situations which would preclude adherence and completion of the protocol;
- the ability to give voluntary informed consent.
Exclusion
- Subjects were excluded from study if they had ever received insulin, metformin, TZDs, exenatide or DPP IV inhibitor.
- All subjects were free of cardiovascular, renal or major organ disease, as determined by medical history, physical examination, screening blood chemistries, complete blood cell count, and electrocardiogram.
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00816218
Start Date
March 1 2003
End Date
November 1 2008
Last Update
May 31 2012
Active Locations (1)
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1
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229