UremiaNCT01391884
Elimination of Incretin Hormones in Patients With Severe Kidney Failure
An observational study of Uremia, run by Bo Feldt-Rasmussen at 1 site in Denmark.
Trial summary
The prevalence of type 2 diabetes (T2D) is increasing rapidly worldwide. T2D is characterized by a severely impaired incretin effect. The incretin effect refers to the insulinotropic action of the nutrient-released incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP). Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Uremia
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2011to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Hemodialysis patients 2. Healthy control subjects
Who may be able to join
- Male or female; aged 18-90 years
- CKD stage 5 in chronic maintenance dialysis treatment
- BMI: 18,5-28 kg/m2
- Normal fasting plasma glucose (<6,1 mM)
- Normal or impaired glucose tolerance (PG120 min <11,1 mM following OGTT)
- Male or female; aged 18-90 years
Show all 11Show fewer
- Healthy including normal kidney function
- BMI: 18,5-28 kg/m2
- Normal fasting plasma glucose (<6,1 mM)
- Normal or impaired glucose tolerance (PG120 min <11,1 mM following OGTT)
- 1+2)
Who cannot join
- Diabetes mellitus
- Chronic pancreatitis / previous acute pancreatitis
- Treatment with oral glucocorticoids, calcineurin inhibitors, thiazides, dipeptidyl peptidase 4 (DPP4) inhibitors or other drugs, which could interfere with glucose or lipid metabolism
- Inflammatory bowel disease
- Malignant disease
- Bowel resection
- Severe anemia (hemoglobin <6.5 mmol/L)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nephrology P, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Copenhagen, 2100
About this study
Official title: Elimination and Biodegradation of the Incretin Hormones GLP-1 and GIP in Patients With End-stage Renal Disease
The prevalence of type 2 diabetes (T2D) is increasing rapidly worldwide. T2D is characterized by a severely impaired incretin effect. The incretin effect refers to the insulinotropic action of the nutrient-released incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP). The incretin effect is defined as the difference in insulin secretory responses between oral and isoglycaemic intravenous glucose challenges (OGTT and IIGI, respectively) and in healthy individuals it accounts for as much as 70% of the insulin response following oral glucose, whereas patients with T2D exhibit an incretin effect in the range of 0 to 30%. Patients with T2D and non-diabetic patients with severe kidney failure share several pathophysiological characteristics, including decreased insulin sensitivity, fasting hyperinsulinaemia and impaired beta-cell function. The reason for these findings remains to be fully elucidated. An ongoing study in our research group is investigating the incretin effect and the incretin hormone secretory responses following OGTT, IIGI and meal ingestion, respectively. In continuation of this study, essential knowledge of metabolism of incretin hormones in an uremic milieu will be obtained in the present study prior to evaluation of the use of incretin-based agents in patients with impaired kidney function. In this second study we evaluate the elimination and biodegradation of GLP-1 and GIP. The biological active incretin hormones are rapidly degraded by the ubiquitous enzyme dipeptidyl peptidase-4 (DPP-4), generating inactive metabolites. The active hormones are however also eliminated by renal clearance, although the importance of this remains questionable. It is likely that the degradation and elimination of the active hormones will be significantly affected in patients with severe kidney impairment.
We hypothesize that elimination and biodegradation of the two incretin hormones, both in it´s active and inactive forms, will be affected in non-diabetic patients with severe kidney failure.
- Conditions
- Uremia
- Keywords
- Incretin hormones, GLP-1, GIP, Uremia, Dialysis
- Medical subject headings
- Uremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dialysis, Non-diabetic | Hemodialysis | |
| Healthy control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intact GLP-1 concentration
During GLP-1 infusion 0-60 min
Measured: -60 min - 180 min
Total GLP-1 concentration
GLP-1 infusion 0-60 min
Measured: -60 min - 180 min
Intact GIP concentration
GIP infusion 0-60 min
Measured: - 60 min - 180 min
Total GIP infusion
GIP infusion 0-60 min
Measured: -60 min - 180 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bo Feldt-Rasmussen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bo Feldt-Rasmussen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391884
- Sponsor's protocol ID
- H-2-2009-158-UREMINC
- Status last verified
- Sep 2012
- First submitted
- 11 Jul 2011
- Last updated
- 19 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Idorn T, Knop FK, Jorgensen MB, Christensen M, Holst JJ, Hornum M, Feldt-Rasmussen B. Elimination and degradation of glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide in patients with end-stage renal disease. J Clin Endocrinol Metab. 2014 Jul;99(7):2457-66. doi: 10.1210/jc.2013-3809. Epub 2014 Apr 8.
PubMed 24712563
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elimination and Biodegradation of the Incretin Hormones GLP-1 and GIP in Patients With End-stage Renal Disease
- ClinicalTrials.gov ID
- NCT01391884
- Acronym / sponsor ID
- H-2-2009-158-UREMINC
- Conditions
- Uremia
- Keywords
- Incretin hormones, GLP-1, GIP, Uremia, Dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bo Feldt-RasmussenUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 12 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prevalence of type 2 diabetes (T2D) is increasing rapidly worldwide. T2D is characterized by a severely impaired incretin effect. The incretin effect refers to the insulinotropic action of the nutrient-released incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP). The incretin effect is defined as the difference in insulin secretory responses between oral and isoglycaemic intravenous glucose challenges (OGTT and IIGI, respectively) and in healthy individuals it accounts for as much as 70% of the insulin response following oral glucose, whereas patients with T2D exhibit an incretin effect in the range of 0 to 30%. Patients with T2D and non-diabetic patients with severe kidney failure share several pathophysiological characteristics, including decreased insulin sensitivity, fasting hyperinsulinaemia and impaired beta-cell function. The reason for these findings remains to be fully elucidated. An ongoing study in our research group is investigating the incretin effect and the incretin hormone secretory responses following OGTT, IIGI and meal ingestion, respectively. In continuation of this study, essential knowledge of metabolism of incretin hormones in an uremic milieu will be obtained in the present study prior to evaluation of the use of incretin-based agents in patients with impaired kidney function. In this second study we evaluate the elimination and biodegradation of GLP-1 and GIP. The biological active incretin hormones are rapidly degraded by the ubiquitous enzyme dipeptidyl peptidase-4 (DPP-4), generating inactive metabolites. The active hormones are however also eliminated by renal clearance, although the importance of this remains questionable. It is likely that the degradation and elimination of the active hormones will be significantly affected in patients with severe kidney impairment.
We hypothesize that elimination and biodegradation of the two incretin hormones, both in it´s active and inactive forms, will be affected in non-diabetic patients with severe kidney failure.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dialysis, Non-diabetic | – | –Hemodialysis |
| Healthy control | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Hemodialysis patients 2. Healthy control subjects
Key inclusion criteria (11 listed)
- Male or female; aged 18-90 years
- CKD stage 5 in chronic maintenance dialysis treatment
- BMI: 18,5-28 kg/m2
- Normal fasting plasma glucose (<6,1 mM)
- Normal or impaired glucose tolerance (PG120 min <11,1 mM following OGTT)
Key exclusion criteria (7 listed)
- Diabetes mellitus
- Chronic pancreatitis / previous acute pancreatitis
- Treatment with oral glucocorticoids, calcineurin inhibitors, thiazides, dipeptidyl peptidase 4 (DPP4) inhibitors or other drugs, which could interfere with glucose or lipid metabolism
- Inflammatory bowel disease
- Malignant disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intact GLP-1 concentration
Time frame: -60 min - 180 min
During GLP-1 infusion 0-60 min
Total GLP-1 concentration
Time frame: -60 min - 180 min
GLP-1 infusion 0-60 min
Intact GIP concentration
Time frame: - 60 min - 180 min
GIP infusion 0-60 min
Total GIP infusion
Time frame: -60 min - 180 min
GIP infusion 0-60 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2012.
- Derived from this study: PubMed 24712563Idorn T, Knop FK, Jorgensen MB, Christensen M, Holst JJ, Hornum M, Feldt-Rasmussen B. Elimination and degradation of glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide in patients with end-stage renal disease. J Clin Endocrinol Metab. 2014 Jul;99(7):2457-66. doi: 10.1210/jc.2013-3809. Epub 2014 Apr 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uremia, run by Bo Feldt-Rasmussen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intact GLP-1 concentration (time frame: -60 min - 180 min). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01391884, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2012.