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PI relocated to a different country and coI moved to a different lab.
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (CON) | Experimental | Placebo will be administered as a subcutaneous injectable bolus, the day prior to the repeated measurement of beta-cell function. |
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| Anakinra (AN) | Experimental | 100 mg of Kineret (Anakinra) will be administered as a subcutaneous injectable bolus, the day prior to the repeated measurement of beta-cell function. |
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| Exercise (EX) | Experimental | 1 hour of cycling exercise will be performed at 75% VO2max, the day prior to the repeated measurement of beta-cell function. |
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| Anakinra + Exercise (ANEX) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anakinra (AN) | Drug |
| ||
| Exercise (EX) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose disposition | The glucose disposal rate during hyperglycemic clamp | 1 day after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas P Solomon, PhD | Rigshospitalet & University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | Denmark |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D053590 | Interleukin 1 Receptor Antagonist Protein |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Behavioral |
|
| Control (CON) | Behavioral |
|
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |