Overview

This trial is active, not recruiting.

Conditions diabetes mellitus, type 2, diabetes mellitus, type 1, end stage renal disease
Treatment adipose tissue biopsy
Sponsor The University of Texas Medical Branch, Galveston
Start date September 2009
End date September 2012
Trial size 15 participants
Trial identifier NCT01729130, IRB 09-043

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Group 1 of patients with End Stage Renal Disease (ESRD) and Diabetes Mellitis who will receive a pancreas and kidney transplant. An adipose tissue biopsy and blood samples are collected at time of transplant surgery. A repeat adipose tissue needle biopsy and blood samples are collected between 3-12 months post transplant.
adipose 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.
Group 2 are patient with DM and ESRD and who will receive only a kidney transplant.
adipose 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.
Group 3 will be patients who do not have DM but do have the diagnosis of ESRD and will receive only a kidney transplant.
adipose 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.

Primary Outcomes

Measure
Change in body fat distribution
time frame: 1 year post transplantation

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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. -

Additional Information

Official title A Pilot Study to Identify the Differences in Adipose Tissue Function After Restoring Normal Glycemic Control Following Pancreas Transplantation
Principal investigator Luca Cicalese, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston.