End-stage Renal Disease Clinical Trial
Verified date | May 2017 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Patients with end-stage renal disease (ESRD) have a high prevalence of impaired glucose
metabolism. The pathophysiological cause is uncertain, but disturbances in the secretion,
elimination and effect of glucagon, insulin and the two incretin hormones glucagon-like
peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), probably play
important roles. Our research group has previously found that dialysis patients without type
2 diabetes mellitus (T2DM) have a reduced incretin effect and an inability to suppress
glucagon after a meal - two early pathophysiological characteristics of patients with T2DM
and normal kidney function.
The aim of the project is to provide a detailed description of the mechanisms underlying the
(patho)physiological effects of the incretin hormones in patients with ESRD. We plan to
investigate the above mentioned disturbances during fasting and hyperglycaemic conditions
using incretin infusions during glucose clamping. Furthermore, stable isotopic tracers will
be used to determine the effect of the incretin hormones on the endogenous glucose handling.
We hypothesise that the effects of the incretin hormones in ESRD will be reduced in respect
to healthy control subjects.
Status | Completed |
Enrollment | 24 |
Est. completion date | April 28, 2016 |
Est. primary completion date | April 28, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria (End-stage renal disease): - Chronic hemodialysis-dependent uremia in more than 3 months Inclusion Criteria (Healthy controls): - Normal kidney function Exclusion Criteria: - Fasting plasma glucose = 6.1 mmol/l - 2h plasma glucose = 7.8 after ingestion of 75 grams of glucose - Admittance to a hospital - Anemia (Hb < 6.0 mmol/l) - Ongoing treatment with drugs interfering with glucose metabolism including steroids and calcineurin inhibitors - Bowel resection or any other large abdominal surgery |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Nephrology, Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Bo Feldt-Rasmussen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The effect of GLP-1 and GIP on insulin response during hyperglycemia between groups | Average plasma insulin concentrations during hyperglycemia | Average during the last 2 hours of each examination day. Blood samples are collected at time 122, 124, 126, 130, 210, 225 and 240 minutes | |
Secondary | The effect of GLP-1 and GIP on insulin, glucagon and endogenous glucose production during euglycemia | Average plasma insulin and glucagon concentrations as well as glucose rate of appearance during euglycemia. | Average during the first 2 hours of each examination day. Blood samples are collected at time 90, 105 and 120 minutes | |
Secondary | The effect of GLP-1 and GIP on early and late phase of insulin, glucagon and endogenous glucose production during hyperglycemia | Average plasma insulin and glucagon concentrations as well as glucose rate of appearance during the first 10 minutes and last 30 minutes of hyperglycemia. | Averages during the last 2 hours of each examination day. Blood samples are collected at time 122, 124, 126, 130, 210, 225 and 240 minutes | |
Secondary | The effect of GLP-1 and GIP on insulin and glucagon response to arginine | Average plasma insulin and glucagon concentrations 10 minutes following arginine bolus at the end of the examination. | Average following ariginine bolus. Blood samples are collected at time 242, 244, 246 and 250 minutes | |
Secondary | The effect of GLP-1 and GIP on the peripheral glucose handling | Average glucose infusion rate during both euglycemia (the first 2 hours) and hyperglycemia (the last 2 hours). | Average during the first 4 hours of each examination day. Blood samples are collected at 5-15 minutes interval from time 0 to time 240 minutes | |
Secondary | The effect of GLP-1 and GIP on potassium concentrations during euglycemia | Average plasma potassium concentrations during euglycemia | Average during the first 2 hours of each examination day. Blood samples are collected at time 30, 60, 90 and 120 minutes |
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