Type 2 Diabetes Mellitus
Conditions
Keywords
Exercise, IL-1RA, Beta-cell function, Type 2 Diabetes
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).
Interventions
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Glucose disposition | 1 day after intervention | The glucose disposal rate during hyperglycemic clamp |
Countries
Denmark
Outcome results
None listed