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NCT Number: NCT02591849

GLP-1 Effects on Insulin and Glucagon in PTDM

Post-transplantation diabetes mellitus (PTDM) develops in 10-15 % of all renal transplant recipients within 10 weeks after transplantation, and has been associated with increased risk of cardiovascular disease and impaired patient survival. PTDM is primarily believed to be a variant of type 2 diabetes mellitus (T2DM), but the pathophysiology underlying the impaired glucose metabolism in renal transplant recipients with PTDM is unclear and some aspects are still poorly investigated. Hyperglycemic clamp investigations with concomitant infusion of glucagon-like peptide-1 (GLP-1) are warranted for a thorough characterization of the α-cell and β-cell function.

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.

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Key information

Conditions

Post-transplant Diabetes Mellitus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital, Rikshospitalet

Oslo, N-0424, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Renal transplant recipients more than 1 year post transplant with stable renal function (less than 20% deviation in serum creatinine within the last 2 months) and stable prednisolone dose (maximum 5 mg/day) the last three months before inclusion
  • 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

  • Severe liver disease
  • 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

Treatment and study plan

Glucagon-like peptide-1 (GLP-1)

Dietary Supplement

Isotonic saline

Other

Hyperglycemic clamp

Other

Primary outcomes

  1. Concentration of glucagon during fasting glycemia and during hyperglycemic conditions measured in picomoles per liter

    Time frame: 4 weeks

    The primary objective of the present study is to measure fasting plasma glucagon concentration and the suppression of glucagon during hyperglycemia (hyperglycemic clamp) measured in picomoles per liter with and without concomitant iv infusion of glucagon-like peptide-1 (GLP-1) in renal transplant recipients with and without PTDM

Secondary outcomes

  1. Glucose-potentiated arginine test

    Time frame: 4 weeks

    Investigate the functional reserve capacity in glucagon and insulin release (measurement of functional α-cell and β-cell mass) by a glucose-potentiated arginine test; since arginine is a glucose-independent stimulator of the release of both hormones.

  2. Insulin sensitivity index

    Time frame: 4 weeks

    Estimate insulin sensitivity index (ISI) by recording the glucose infusion rate during the hyperglycemic clamp, corrected for the prevailing plasma insulin concentrations.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

GLP-1 Restores Altered Insulin and Glucagon Secretion in Post-transplantation Diabetes Mellitus

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 30, 2015
Registry last updated
Mar 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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