Insulin Secretory Capacity in Insulin-independent Pancreas-Kidney Recipients Compared to Controls

University Hospital, Gasthuisberg

Status: Unknown

Conditions: Pancreas Transplantation; Kidney Transplantation

Treatments: Other: hyperglycemic clamp test

Study type: Interventional

Funder types: Other

Identifiers

NCT00618761

clamp01

JDRF 4/2005/1327

Details and patient eligibility

About

The purpose of this study is to compare functional beta-cell mass using the hyperglycaemic clamp test in insulin-independent pancreas-kidney recipients with that in non-diabetic kidney recipients and normal controls as well as with the partially previously reported data in beta-cell recipients.

Enrollment: 40 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• kidney pancreas recipients
• kidney recipients
• healthy volunteers
• beta-cell recipients
• immunosuppression with MMF-Tacrolimus
• 1-4 years after transplantation

Exclusion criteria

• high doses of steroids
• insulin dependent

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

1

Experimental group

Description:

kidney-pancreas recipients

Treatment:

Other: hyperglycemic clamp test

2

Active Comparator group

Description:

kidney recipients

Treatment:

Other: hyperglycemic clamp test

3

Active Comparator group

Description:

healthy controls

Treatment:

Other: hyperglycemic clamp test

4

Active Comparator group

Description:

beta-cell recipients

Treatment:

Other: hyperglycemic clamp test