Adipose Tissue Function After Pancreas Transplantation

NCT01729130 | Completed

• 1 other identifier: IRB 09-043
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in body fat distribution

  skinfold thickness changes from baseline to within 1 year post transplantation using tape measure, scale and calipers

  1 year post transplantation

Study Arms (3)

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.

Procedure: Adipose tissue biopsy

Group 2 DM with kidney transplant

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

Procedure: Adipose tissue biopsy

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.

Procedure: Adipose tissue biopsy

Interventions

Adipose tissue biopsy 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 1 Pancreas/kidney transplant; Group 2 DM with kidney transplant; Group 3 No DM and kidney transplant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients that have Diabetes mellitis and End Stage Renal Disease who will be receiving pancreas/kidney or only kidney transplantation. Patients that have End Stage Renal Disease and who will be receiving an isolated kidney transplant. This control group will account for effects of immuno-suppression and for potential metabolic changes induced by the kidney transplant on adipose tissue function.

You may qualify if:

• Men and women of any ethnicity, and age between 18 and 65 years.
• Patients with diabetes and renal failure who have been scheduled kidney-pancreas or isolated kidney transplantation.
• Ability to speak read and understand English or Spanish

You may not qualify if:

• Any evidence of acute or severe cardiopulmonary, thyroid, neurological disorders, as assessed by history and physical examination and laboratory testing.
• Any personal history of substance abuse (reported only).
• Alcohol intake above 7 grams/day.
• Pregnancy or lactation.
• Inability to give consent for this study.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

The University of Texas Medical Branch (UTMB)

Galveston, Texas, 77555, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

adipose tissue blood samples

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Luca Cicalese, MD

  UTMB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2012
• First Posted: November 20, 2012
• Study Start: September 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: February 19, 2019
• Last Updated: March 1, 2019

Record last verified: 2019-02

Locations

US (1)