IL-1RA, Acute Exercise, and Beta-cell Function

Type 2 Diabetes Mellitus Clinical Trial

— ANEX  

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02310009
• Other study ID #: ANEX
• Status: Withdrawn
• Phase: N/A
• First received: December 2, 2014
• Last updated: February 10, 2017
• Start date: December 2014
• Est. completion date: July 30, 2015

Study information

• Verified date: February 2017
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Subjects (N=48) with poorly-controlled type 2 diabetes (HbA1c>7%) will be assigned to one of the 4 following interventions in a randomised, parallel group design: [I] Control (placebo injection; no exercise), [II] Anakinra (100 mg subcutaneous injection of human recombinant interleukin-1 receptor antagonist), [III] Exercise (1 h cycle ergometry at 75% VO2max), [IV] Anakinra + Exercise. Pancreatic beta-cell function (plasma insulin responses) will be measured before and after each intervention using a hyperglycemic clamp (5.4 mM above basal glucose) combined with GLP-1 infusion (0.5 pmol/kg/min) and arginine injection (5 g bolus).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 30, 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes with HbA1c >7%

Exclusion Criteria:

• HbA1c >7%

• Age <30 or >80 y

• BMI <25 or >40 kg/m2

• Pregnancy

• Evidence of chronic haematological/renal/hepatic/pulmonary/heart disease

• >2kg weight change in prior 6 months

• Alcohol consumption (men: >14 drinks/week; women: >7 drinks/week)

• Smoking

• Physical activity of >150 min/week

• Contraindication to exercise

• Contraindication to use of anakinra

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Anakinra (AN)

Behavioral:
• Exercise (EX)

• Control (CON)

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beta-cell function	A hyperglycemic clamp will be performed combined with glucagon-like peptide(GLP)-1 infusion and arginine injection. The primary outcome is the insulin secretory response to glucose, GLP-1, and arginine.	1 day after intervention
Secondary	Glucose disposition	The glucose disposal rate during hyperglycemic clamp	1 day after intervention