Glucose Metabolism During Hemodialysis

NCT01800188 | Completed

• 1 other identifier: H-2-2012-171
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Disturbed glucose metabolism is a common feature of patients with end-stage renal disease (ESRD). Several hormones responsible of a stable blood glucose including insulin, glucagon, and the gastrointestinal insulinotropic hormones Glucagon-like Peptide-1 (GLP-1) and Glucose-dependent Insulinotropic Peptide (GIP) are elevated in patients with ESRD. These hormones are all medium sized peptides which theoretically makes them removable during high efficient hemodialysis. A significant removal could have consequences for the treatment of patients with diabetes and ESRD. The purpose of this study is to determine whether insulin, glucagon, GLP-1 and GIP are cleared during high efficient hemodialysis and hemodiafiltration. The investigators hypothesize that a significant amount of these hormones is removed during hemodialysis and to a larger extend during hemodiafiltration.

Conditions

ESRD

Keywords

Dialysis; Incretin hormones

Outcome Measures

Primary Outcomes (3)

• Clearance of total GLP-1

  Clearance,K, is defined as K=Qb\*(Ca-Cv)/Ca+Qf\*Cv/Ca where Qb is the effective blood flow, Ca is the concentration before the filter, Cv is the concentration after the filter and Qf is the ultrafiltration flow.

  2 hours into dialysis

• Clearance of total GIP

  Clearance,K, is defined as K=Qb\*(Ca-Cv)/Ca+Qf\*Cv/Ca where Qb is the effective blood flow, Ca is the concentration before the filter, Cv is the concentration after the filter and Qf is the ultrafiltration flow.

  2 hours into dialysis

• Clearance of glucagon

  Clearance,K, is defined as K=Qb\*(Ca-Cv)/Ca+Qf\*Cv/Ca where Qb is the effective blood flow, Ca is the concentration before the filter, Cv is the concentration after the filter and Qf is the ultrafiltration flow.

  One hour into dialysis

Secondary Outcomes (5)

• Change of insulin clearance at 2 hours into dialysis

  Baseline and 2 hours into dialysis

• Change of hormone concentrations

  Baseline and 1 hour into dialysis

• The percentage of cleared hormone present in the dialysate

  One or two hours into the dialysis

• Change of insulin clearance at 3 hours into dialysis

  Baseline and 3 hours into dialysis

• Change of insulin clearance at 4 hours into dialysis

  Baseline and 4 hours into dialysis

Study Arms (1)

Dialysis

Patients with dialysis dependent ESRD and normal fasting glucose will undergo a meal test during a hemodialysis and hemodiafiltration session. A meal test without dialysis is optional.

Procedure: Hemodialysis; Procedure: Hemodiafiltration; Procedure: Meal test

Interventions

Hemodialysis PROCEDURE

A 4 hour hemodialysis with a standardized liquid meal after one hour

Dialysis

Hemodiafiltration PROCEDURE

A 4 hour hemodiafiltration with a standardized liquid meal after one hour

Dialysis

Meal test PROCEDURE

A 3 hour standardized liquid meal test without dialysis

Dialysis

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ESRD undergoing chronic hemodialysis/hemodiafiltration and with a normal fasting glucose

You may qualify if:

• Aged 18-90 years
• Dialysis-dependent ESRD for more than 3 months
• Regular treatment with either hemodialysis or hemodiafiltration
• A well functioning arteriovenous fistula
• Fistula flow ≥ 400 ml/min

You may not qualify if:

• Diabetes mellitus
• Impaired fasting glucose (fasting plasma glucose ≥ 6.1 mmol/l)
• Current illness requiring admission to the hospital
• Significant acidosis before dialysis (standardized bicarbonate \< 20 mmol/l)
• Anemia (B-Hemoglobin \< 6,0 mmol/l)
• Known allergy to Paracetamol
• Medical treatment with compounds of known diabetogenic and / or insulin secretion inhibitory effect, including steroids and calcineurin inhibitors.
• Bowel resection or other major surgery of the gastrointestinal tract
• Current malignancy not including basal cell carcinoma

Sponsors & Collaborators

• Bo Feldt-Rasmussen: lead

Study Sites (1)

Nephrology department, Rigshospitalet

Copenhagen, Copenhagen, 2100, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum of blood specimens will be retained for analysis at the end of the study

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Renal Dialysis; Hemodiafiltration

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Sorption Detoxification; Hemofiltration; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Bo Feldt-Rasmussen, MD DMSc

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD DMSc

Study Record Dates

• First Submitted: February 25, 2013
• First Posted: February 27, 2013
• Study Start: February 1, 2013
• Primary Completion: September 1, 2013
• Last Updated: November 19, 2013

Record last verified: 2013-11

Locations

DK (1)