A Pilot Study to Identify the Differences in Adipose Tissue Function After Restoring Normal Glycemic Control Following Pancreas Transplantation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT01729130
First received: November 13, 2012
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
End Stage Renal Disease
Procedure: Adipose tissue biopsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study to Identify the Differences in Adipose Tissue Function After Restoring Normal Glycemic Control Following Pancreas Transplantation

Resource links provided by NLM:


Further study details as provided by The University of Texas, Galveston:

Primary Outcome Measures:
  • Change in body fat distribution [ Time Frame: 1 year post transplantation ] [ Designated as safety issue: No ]
    skinfold thickness changes from baseline to within 1 year post transplantation using tape measure, scale and calipers


Biospecimen Retention:   Samples With DNA

adipose tissue blood samples


Enrollment: 15
Study Start Date: September 2009
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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.
Procedure: 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 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
Adipose tissue biopsy is done at time of transplant surgery. There is a second needle biopsy done between 3-12 months post transplant surgery.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.

    -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01729130

Locations
United States, Texas
The University of Texas Medical Branch (UTMB)
Galveston, Texas, United States, 77555
Sponsors and Collaborators
The University of Texas, Galveston
Investigators
Principal Investigator: Luca Cicalese, MD UTMB
  More Information

No publications provided

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT01729130     History of Changes
Other Study ID Numbers: IRB 09-043
Study First Received: November 13, 2012
Last Updated: September 30, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Kidney Diseases
Kidney Failure, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Pancreatin
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014