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

Not Applicable

Withdrawn

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Anakinra (AN); Behavioral: Exercise (EX); Behavioral: Control (CON)

• Registration Number: NCT02310009
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-02
• Study First Submitted QC: 2014-12-04
• Study First Posted: 2014-12-05
• Primary Completion: 2015-06
• Study Completion: 2015-07-30
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-10
• Last Update Posted: 2017-02-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anakinra + Exercise (ANEX)	Anakinra (AN)	100 mg of Kineret (Anakinra) will be administered as a subcutaneous injectable bolus followed by 1 hour of cycling exercise at 75% VO2max, the day prior to the repeated measurement of beta-cell function.
Exercise (EX)	Exercise (EX)	1 hour of cycling exercise will be performed at 75% VO2max, the day prior to the repeated measurement of beta-cell function.
Control (CON)	Control (CON)	Placebo will be administered as a subcutaneous injectable bolus, the day prior to the repeated measurement of beta-cell function.
Anakinra + Exercise (ANEX)	Exercise (EX)	100 mg of Kineret (Anakinra) will be administered as a subcutaneous injectable bolus followed by 1 hour of cycling exercise at 75% VO2max, the day prior to the repeated measurement of beta-cell function.
Anakinra (AN)	Anakinra (AN)	100 mg of Kineret (Anakinra) will be administered as a subcutaneous injectable bolus, the day prior to the repeated measurement of beta-cell function.

Primary Outcome Measures

Name	Time	Method
Beta-cell function	1 day after intervention	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.

Secondary Outcome Measures

Name	Time	Method
Glucose disposition	1 day after intervention	The glucose disposal rate during hyperglycemic clamp

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark