Adipose Tissue Function After Pancreas Transplantation

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01729130
• Other study ID #: IRB 09-043
• Status: Completed
• Start date: September 2009
• Est. completion date: February 19, 2019

Study information

• Verified date: February 2019
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

detailed description is his protocol

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 19, 2019
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Texas Medical Branch (UTMB)	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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