Glucose Control in Pre-Diabetic Renal Transplant Patients (GCPD)

Marcus Saemann

Status and phase: Completed; Phase 2

Conditions: Impaired Glucose Tolerance; Kidney Transplantation

Treatments: Behavioral: Life-Style Modification; Drug: Pioglitazone; Drug: Vildagliptin

Study type: Interventional

Funder types: Other

Identifiers

NCT01346254

GCPD

Details and patient eligibility

About

Development of New-Onset Diabetes after Transplantation (NODAT) is common and serious complication after kidney transplantation. Patients who develop NODAT are at increased risk for loss of the transplanted organ and for diseases of the cardiovascular system.

It is believed that in many patients the development of overt NODAT is preceded by a phase of impaired glucose tolerance that is called pre-diabetes.

This study aims at improving glucose metabolism in patients after kidney transplantation who are in a pre-diabetic metabolic state. Patients who exhibit impaired glucose tolerance (IGT) after kidney transplantation are randomized to either receive vildagliptin (Galvus), pioglitazone(Actos) or placebo for three months.

The investigators hypothesize that treatment with vildagliptin or pioglitazone leads to improved glycemic control compared to placebo.

Enrollment: 51 patients

Sex: All

Ages: 18 to 81 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Time since renal transplantation > 6 months
• Stable graft function
• Routine OGTT has been performed, and pre-diabetes has been diagnosed by pathological OGTT (2h, 75 g glucose, glucose level between 140 and 200 mg/dl)
• Informed consent of the patient

Exclusion criteria

• Patients with type 1 or type 2 diabetes
• Patients with NODAT (2h glucose level at OGTT >200 mg/dl)
• allergy against vildagliptin or pioglitazone
• pregnancy
• GFR<15ml/min/1.73 with need for dialysis
• hepatic impairment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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51 participants in 3 patient groups, including a placebo group

Vildagliptin

Experimental group

Description:

16 patients randomized into this arm will receive vildagliptin (Galvus) 50mg orally once daily

Treatment:

Drug: Vildagliptin

Behavioral: Life-Style Modification

Pioglitazone

Experimental group

Description:

16 patients randomized into this arm will receive pioglitazone (Actos) 30mg orally once daily

Treatment:

Behavioral: Life-Style Modification

Drug: Pioglitazone

Placebo

Placebo Comparator group

Description:

16 patients randomized into this arm will receive placebo medication orally once daily

Treatment:

Behavioral: Life-Style Modification