Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2014-10-31
2015-03-31
Brief Summary
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The primary objective of the present study is to investigate whether hyperglucagonemia is present in renal transplant recipients with PTDM. Furthermore, the investigators aim to examine the insulinotropic and glucagon suppressive effects of GLP-1 (compared to placebo) in PTDM patients during fasting glycemia and during hyperglycemic conditions (hyperglycemic clamp), respectively.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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Glucagon-like peptide-1 (GLP-1)
Twelve eligible renal transplant recipients with PTDM and twelve age, gender, BMI and renal function-matched non-diabetic renal transplant recipients will be randomized to continuous unblinded intravenous infusion of GLP-1 with an infusion rate of 0.8 pmol/kg/min or isotonic saline (placebo) on two experimental days performed 2-4 weeks apart. The GLP-1 infusion will consist of 42.5 nmol/mL GLP-1 (7-36) amide, 12.5 mL 5% human albumin and isotonic saline added to a total volume of 50 mL. After 60 min, a 2 hour hyperglycemic clamp will be initiated, where plasma glucose will be elevated by 5 mmol/L from each individual fasting plasma glucose in both groups. This will be done to measure concentrations of glucagon and insulin in hyperglycemic conditions.
Glucagon-like peptide-1 (GLP-1)
Hyperglycemic clamp
Isotonic saline
The included patients will receive concomitant intravenous infusion of isotonic saline on one of the two experimental days
Isotonic saline
Hyperglycemic clamp
Interventions
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Glucagon-like peptide-1 (GLP-1)
Isotonic saline
Hyperglycemic clamp
Eligibility Criteria
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Inclusion Criteria
* Diagnose of PTDM on standard clinical follow-up performed 8 weeks and 1 year post transplant at OUS-Rikshospitalet (fasting plasma glucose ≥ 7.0 mmol/l and/or 2-hour plasma glucose ≥ 11.1 mmol/l following an oral glucose tolerance test) OR
* Non-diabetic renal transplant recipients with a normal glucose tolerance test (control group)
* \> 18 years of age
* BMI 18.5-29.9 kg/m2
* Signed informed consent
Exclusion Criteria
* Pancreatitis (chronic or acute), previous bowel resection, inflammatory bowel disease, malignancy (previous or actual)
* Estimated GFR \< 25 ml/min/1.73 m2
* Pregnant or nursing mothers
18 Years
ALL
Yes
Sponsors
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Oslo University Hospital
OTHER
Responsible Party
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Trond Jenssen
Professor
Locations
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Oslo University Hospital, Rikshospitalet
Oslo, Oslo County, Norway
Countries
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References
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Halden TA, Egeland EJ, Asberg A, Hartmann A, Midtvedt K, Khiabani HZ, Holst JJ, Knop FK, Hornum M, Feldt-Rasmussen B, Jenssen T. GLP-1 Restores Altered Insulin and Glucagon Secretion in Posttransplantation Diabetes. Diabetes Care. 2016 Apr;39(4):617-24. doi: 10.2337/dc15-2383. Epub 2016 Feb 23.
Other Identifiers
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2014/666
Identifier Type: -
Identifier Source: org_study_id