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

Not Applicable

• Conditions: Kidney Transplantation; Pancreas Transplantation
• Interventions: Other: hyperglycemic clamp test

• Registration Number: NCT00618761
• Lead Sponsor: University Hospital, Gasthuisberg

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Status Verified: 2008-01
• Study First Submitted: 2008-02-06
• Study First Submitted QC: 2008-02-06
• Study First Posted: 2008-02-20
• Last Update Submitted: 2012-06-14
• Last Update Posted: 2012-06-15
• Primary Completion: 2014-01
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	hyperglycemic clamp test	kidney recipients
3	hyperglycemic clamp test	healthy controls
4	hyperglycemic clamp test	beta-cell recipients
1	hyperglycemic clamp test	kidney-pancreas recipients

Primary Outcome Measures

Name	Time	Method
insulin secretion during clamp test	time 0

Trial Locations

Locations (1)

Department of Endocrinology, Leuven, UZ-Gasthuisberg; 🇧🇪 Leuven, Belgium