Clinical trial NCT01729130: Adipose Tissue Function After Pancreas Transplantation
Official title: A Pilot Study to Identify the Differences in Adipose Tissue Function After Restoring Normal Glycemic Control Following Pancreas Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
End Stage Renal Disease
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2012-11-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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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Primary outcomes:
measure: Change in body fat distribution
timeFrame: 1 year post transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: The University of Texas Medical Branch (UTMB)
state: Texas
Study officials:
affiliation: UTMB
name: Luca Cicalese, MD
role: PRINCIPAL_INVESTIGATOR
References: