IL-1RA, Acute Exercise, and Beta-cell Function (ANEX)

Rigshospitalet

Status: Withdrawn

Conditions: Type 2 Diabetes Mellitus

Treatments: Behavioral: Exercise (EX); Drug: Anakinra (AN); Behavioral: Control (CON)

Study type: Interventional

Funder types: Other

Identifiers

NCT02310009

ANEX

Details and patient eligibility

About

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).

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 4 patient groups

Control (CON)

Experimental group

Description:

Placebo will be administered as a subcutaneous injectable bolus, the day prior to the repeated measurement of beta-cell function.

Treatment:

Behavioral: Control (CON)

Anakinra (AN)

Experimental group

Description:

100 mg of Kineret (Anakinra) will be administered as a subcutaneous injectable bolus, the day prior to the repeated measurement of beta-cell function.

Treatment:

Drug: Anakinra (AN)

Exercise (EX)

Experimental group

Description:

1 hour of cycling exercise will be performed at 75% VO2max, the day prior to the repeated measurement of beta-cell function.

Treatment:

Behavioral: Exercise (EX)

Anakinra + Exercise (ANEX)

Experimental group

Description:

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.

Treatment:

Drug: Anakinra (AN)

Behavioral: Exercise (EX)