Adipose Tissue Function After Pancreas Transplantation

NCT ID: NCT01729130

Last Updated: 2019-03-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2019-02-19

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

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; End Stage Renal Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1 Pancreas/kidney transplant

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

Intervention Type: PROCEDURE

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 DM with kidney transplant

Group 2 are patient with DM and ESRD and who will receive only a kidney transplant.

Adipose tissue biopsy

Intervention Type: PROCEDURE

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 No DM and kidney transplant

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

Intervention Type: PROCEDURE

Adipose tissue biopsy is done at time of transplant surgery. There is a second needle biopsy done between 3-12 months post transplant surgery.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luca Cicalese, MD

Role: PRINCIPAL_INVESTIGATOR

UTMB

Locations

The University of Texas Medical Branch (UTMB)

Galveston, Texas, United States

Countries

United States

Other Identifiers

IRB 09-043

Identifier Type: -

Identifier Source: org_study_id