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Vascular Dysfunction in Type II Diabetes

Study Description

Participants will be screened for Diabetes Type II and Hypertension and asked to participate in a study that will last approximately 2-3 weeks.  They will first be given a five day diet to follow (all food provided by the study) and then be asked to spend 2 days in the General Clinical Research Center (GCRC) having blood tests and studies, urine tests, and frequent blood pressure readings.

They will then go home on a five day very low salt diet (all food provided by the study) and then re-enter the GCRC for the same two day stay and battery of tests.  Genotyping will also be done to determine which genes might be involved in changing the risk in someone with diabetes of developing heart or kidney disease or of developing hypertension.

Contact Information

Status:

Name, Phone, Email:
Deborah Burton, RN,
801-585-6745
801-585-1566
Deborah.burton@hsc.utah.edu

Principle Investigator:
Donald McClain, M.D., PhD

Please Note:

Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician, we can help you find a University of Utah doctor or clinic location to meet your health care needs.

Although the studies described on this Web site may have potential benefits as described, the University of Utah and its physicians and affiliated hospitals cannot and do not guarantee or promise that you will receive any benefits from participating in a study.

Participant Eligibility

Inclusion Criteria:

Group I:   High Blood Pressure/Type 2 Diabetes
Group II:  Normal Blood Pressure/ Type 2 Diabetes

18-65 years of age
HgA1c < 8%
BMI < 36
HTN:     BP > 135/85 on no anti-htn meds
              BP > 130/80 on one med
              On two or more anti-htn meds
Document
            Medical Therapy
            Past Medical History

Subjects of child bearing age must use a barrier method of contraceptive protection.

Exclusion Criteria:
  1. Pt with secondary HTN
  2. Pt with renal disease (with the exception of microalbuminemia, <100mg albumin/g creatinine)
  3. Pt with retinopathy requiring laser tx
  4. Pt with known coronary artery, peripheral vascular or cerebral vascular disease
  5. Pt with recent MI, CVA or active malignancy
  6. Pt with HgA1c > 8 % (may see MD to receive oral hypoglycemic agents)
  7. Systolic BP > 160 mmHG
  8. Diastolic BP > 100 mmHG
  9. If spot urine shows NA > 30 after low salt diet, pt will not be included in the study
  10. Pregnancy
  11. Pt with excessive alcohol use (> 12 oz ETOH/week)
  12. Pt using recreational drugs
  13. Smokers unwilling to refrain from smoking for 72 hours prior to inpatient study
  14. Creatinine clearance must be within normal limits according to each site’s laboratory calculations 15) (per the MDRD formula)
  15. Pt with abnormal labs
  16. Pt with > 50% renal artery stenosis

How long does the study run?

Study will run for 5 years.

Location(s) of the Clinical Trial

University of Utah Medical Center
Salt Lake City, UT 84132