The Prospective Evaluation of Pancreatic Function in Pancreas Transplant Recipients

NCT00571818 | Completed

• 1 other identifier: 0114-00-FB
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to understand how the pancreas functions after transplantation and particularly why high blood sugar levels develop. It will also analyze the effect of the medicines used to prevent rejection on blood sugar levels. The hypothesis to be tested is that hyperglycemia more than six months after successful pancreas transplant results from a defect in insulin secretion, insulin resistance, or both.

Conditions

Transplant; Diabetes

Keywords

euglycemic; transplant; pancreas; hyperglycemic; kidney

Outcome Measures

Primary Outcomes (2)

• Evaluate beta cell secretion

  Evaluate beta cell secretion by oral glucose tolerance test (done over 2 hours) and IV Glucose Tolerance Test (done over 4 hours)

  9 months post-transplant or at time of participation for controls

• Evaluate insulin sensitivity/glucose effectiveness

  Evaluate insulin sensitivity/glucose effectiveness by oral glucose tolerance test (done over 2 hours) and IV Glucose Tolerance Test (done over 4 hours)

  9 months post-transplant or at time of participation for controls

Study Arms (4)

Euglycemic pancreas transplant recipients

ACTIVE COMPARATOR

Participants receiving a pancreas transplant who have blood glucose level is within the normal range

Procedure: Oral glucose tolerance test; Procedure: IV Glucose Tolerance Test

Hyperglycemic pancreas transplant recipients

ACTIVE COMPARATOR

Participants receiving a pancreas transplant who have high blood glucose (blood sugar)

Procedure: Oral glucose tolerance test; Procedure: IV Glucose Tolerance Test

Euglycemic Kidney Transplant Recipients

ACTIVE COMPARATOR

Participants receiving a kidney transplant who have blood glucose level is within the normal range

Procedure: Oral glucose tolerance test; Procedure: IV Glucose Tolerance Test

Euglycemic Healthy Control Participants

ACTIVE COMPARATOR

Participants who do not receive either a pancreas or kidney transplant who have blood glucose level is within the normal range

Procedure: Oral glucose tolerance test; Procedure: IV Glucose Tolerance Test

Interventions

Oral glucose tolerance test PROCEDURE

test done over 2 hours

Euglycemic Healthy Control Participants; Euglycemic Kidney Transplant Recipients; Euglycemic pancreas transplant recipients; Hyperglycemic pancreas transplant recipients

IV Glucose Tolerance Test PROCEDURE

Done over 4 hours

Euglycemic Healthy Control Participants; Euglycemic Kidney Transplant Recipients; Euglycemic pancreas transplant recipients; Hyperglycemic pancreas transplant recipients

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hyperglycemic pancreas transplant recipients:
• ages 19-65
• received a pancreas transplant ≥ 9 months previously
• fasting glucose levels ≥ 126 mg/dl
• hemoglobin A1C \> 1% above normal
• Euglycemic pancreas transplant recipients:
• ages 19-65
• received a pancreas transplant ≥ 9 months previously
• fasting glucose levels are \< 126 mg/dl
• normal HbA1C without taking any medications for the treatment of high blood sugars.
• Euglycemic Kidney Transplant Recipients:
• ages 19-65
• no prior diagnosis of diabetes
• received a kidney transplant ≥ 9 months previously
• showing continued function

You may not qualify if:

• Hyperglycemic pancreas transplant recipients:
• chronic illnesses that would decrease insulin sensitivity (
• terminal illness
• BMI \> 30 kg/m2
• serum creatinine \> 2 mg/dl
• hemoglobin \< 10 g/dl
• an episode of acute rejection with the preceding 3 months of entry.
• Euglycemic pancreas transplant recipients:
• no diagnosis of type 2 diabetes.
• Euglycemic Kidney Transplant Recipients:
• Euglycemic Healthy Control Subjects:
• chronic illnesses
• medications known to affect glucose metabolism
• a history of smoking
• serum creatinine ≥ 1.5 mg/dl

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Officials

• James T Lane, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2007
• First Posted: December 12, 2007
• Study Start: November 1, 2000
• Primary Completion: March 1, 2008
• Study Completion: June 1, 2010
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

US (1)