NCT01327378

Brief Summary

The current study explores the incretin effect; a central mechanism of sugar metabolism. People with type 2 diabetes have a markedly reduced incretin effect, while the incretin effect never has been studied in patients with severe chronic renal failure. Non-diabetic patients with severe kidney failure and patients with diabetes and normal kidney function share several pathophysiological traits, including decreased sensitivity to insulin, fasting hyperinsulinaemia and impaired beta cell function. The investigators expect the incretin effect to be affected in patients with chronic renal failure without diabetes, which in time can result in therapeutic changes in this group of patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2011

Completed
Last Updated

April 1, 2011

Status Verified

June 1, 2010

Enrollment Period

1.6 years

First QC Date

March 29, 2011

Last Update Submit

March 31, 2011

Conditions

Renal Insufficiency, Chronic

Outcome Measures

Primary Outcomes (1)

  • Incretin effect

    IE= 100%\*(iAUC,OGTT - iAUC,IIGI)/iAUC,OGTT Assessed at two separate examination days. Day 1: Oral glucose tolerance test (OGTT), Day 2: Intravenous isoglycaemic glucose infusion (IIGI). Data will be presented when all analyses have been performed. Estimated in May 2011.

    Minimum 3 days and maximum 3 weeks between the two examination days. Cross-sectional design. No follow up.

Secondary Outcomes (1)

  • Gastric-induced glucose disposal (GIGD)

    Minimum 3 days and maximum 3 weeks between the two examination days. Cross-sectional design. No follow up.

Study Arms (3)

Dialysis, normal glucose tolerance

Chronic dialysis treatment, N=10 OGTT,120 min \< 7.8 mmol/L

Dialysis, impaired glucose tolerance

Chronic dialysis treatment, N=10 OGTT,120 min 7.7\<11.1 mmol/L

Control, normal glucose tolerance

Healthy Control subjects, N=10 OGTT,120 min \<7.8 mmol/L

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

3 groups 1. Chronic hemodialysis treatment. Normal glucose tolerance (NGT). N=10 2. Chronic hemodialysis treatment. Impaired glucose tolerance (IGT). N=10 3. Healthy control subjects. Normal glucose tolerance. N=10 Glucose tolerance is evaluated at the screeningday. A 75 gram oral glucose tolerance test (OGTT) is performed and the 120 minute value sets the glucose tolerance. NGT: \< 7.8 mmol/L, IGT: \> 7.7 mmol/L and \< 11.1 mmol/L (according to WHO guidelines).

You may qualify if:

  • Male or female; age: 18 - 90 years
  • CKD stage 5 (CrCL \< 15 ml/min) in chronic haemodialysis (minimum 3 months)
  • NGT or IGT (diagnosed according to WHO criteria)
  • Body mass index 18.5 - 28 kg/m2

You may not qualify if:

  • Type 1 or 2 diabetes mellitus
  • Pancreatitis
  • Medication with influence on insulin secretion and/or glucose metabolism
  • Previous or actual malignancy
  • Inflammatory bowel disease
  • Congestive heart failure (NYHA III-IV)
  • Previous bowel resection
  • Severe hypertension
  • Impaired liver function
  • Haemoglobin \< 6.5 mmol/L

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nephrology P 2131, Rigshospitalet

Copenhagen Ø, 2100, Denmark

Location

Related Publications (2)

  • Wewer Albrechtsen NJ, Hartmann B, Veedfald S, Windelov JA, Plamboeck A, Bojsen-Moller KN, Idorn T, Feldt-Rasmussen B, Knop FK, Vilsboll T, Madsbad S, Deacon CF, Holst JJ. Hyperglucagonaemia analysed by glucagon sandwich ELISA: nonspecific interference or truly elevated levels? Diabetologia. 2014 Sep;57(9):1919-26. doi: 10.1007/s00125-014-3283-z. Epub 2014 Jun 3.

    PMID: 24891019DERIVED

  • Idorn T, Knop FK, Jorgensen M, Holst JJ, Hornum M, Feldt-Rasmussen B. Gastrointestinal factors contribute to glucometabolic disturbances in nondiabetic patients with end-stage renal disease. Kidney Int. 2013 May;83(5):915-23. doi: 10.1038/ki.2012.460. Epub 2013 Jan 16.

    PMID: 23325073DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma (10 ml per participant)

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bo Feldt-Rasmussen, Prof, DMSc

    Department of Nephrology, Rigshospitalet, University of Copenhagen, Denmark

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 29, 2011

First Posted

April 1, 2011

Study Start

March 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

April 1, 2011

Record last verified: 2010-06

Locations

DK(1)