Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, End Stage Renal Disease
Conditions
Brief summary
Clinical measures of adipose tissue mass (BMI, waist circumference, waist-to-hip ratio) do not adequately explain the inter-individual and ethnic heterogeneity in diabetes. . There is a need to identify novel/universal markers of risk for diabetes (DM) and cardiovascular disease (CVD). These biomarkers also can become additional outcome measures for an intervention such as pancreatic/kidney transplant. If biological markers show an improvement with an intervention before anthropometric changes occur, intermediate outcomes can be an encouraging finding for practitioners. This study will focus on the central question of adipose tissue dysfunction as mediator of metabolic complications of positive energy balance, independent of body fat content and distribution. This study will address the question of effect of hyperglycemia on adipose tissue function independent of body fat mass. This project will take advantage of unique expertise of our investigators to perform detailed metabolic studies in patients with diabetes who undergo pancreatic/kidney transplant. The results of the proposed study will provide support to the novel approach of identifying adipose tissue dysfunction, rather than obesity and fat distribution, as predictor of diabetes and CVD across all ethnic groups, age and gender. We will obtain necessary preliminary data for future grant submissions to support our central hypothesis and develop stronger interactions within and outside The University of Texas Medical Branch (UTMB) with clinical investigators in the area of DM and its complications.
Detailed description
detailed description is his protocol
Interventions
PROCEDUREAdipose tissue biopsy
Adipose tissue biopsy is done at time of transplant surgery. There is a second needle biopsy done between 3-12 months post transplant surgery.
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Men and women of any ethnicity, and age between 18 and 65 years. 2. Patients with diabetes and renal failure who have been scheduled kidney-pancreas or isolated kidney transplantation. 3. Ability to speak read and understand English or Spanish
Exclusion criteria
1. Any evidence of acute or severe cardiopulmonary, thyroid, neurological disorders, as assessed by history and physical examination and laboratory testing. 2. Any personal history of substance abuse (reported only). 3. Alcohol intake above 7 grams/day. 4. Pregnancy or lactation. 5. Inability to give consent for this study. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in body fat distribution | 1 year post transplantation | skinfold thickness changes from baseline to within 1 year post transplantation using tape measure, scale and calipers |
Countries
United States
Outcome results
None listed