Role of Interleukin-6 in Exercise (Exil-6)

University of Zurich (UZH)

Status: Completed

Conditions: Obesity; Diabetes Mellitus, Type 2

Treatments: Drug: Sitagliptin; Drug: Tocilizumab; Behavioral: Sport

Study type: Interventional

Funder types: Other

Identifiers

NCT01073826

Donath-1

Details and patient eligibility

About

The purpose of the study is to understand the role of interleukin-6 during physical activity in patients with type 2 diabetes.

Enrollment: 56 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Obesity group: BMI 30-40 kg/m2, fasting plasma glucose <6.4 mmol/l.
• Diabetes group: Type 2 diabetes according to American Diabetes Association criteria

Exclusion criteria

• Anti-diabetic drug other than metformin
• Diabetes duration of more than 5 years
• Inflammatory diseases
• Current infection
• Liver disease (transaminases >2x upper normal range)
• kidney disease (creatinine >1.5 mg/dl for men and 1.4 mg/dl for women)
• pregnancy or breast-feeding, women of child bearing potential not using an acceptable form of contraception
• immunosuppressive disease
• corticosteroid use
• regular non-steroidal antinflammatory drug usage
• history of carcinoma
• history of tuberculosis
• anemia, bleeding disorders
• obstructive pulmonary disease.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 3 patient groups, including a placebo group

Tocilizumab

Active Comparator group

Description:

Infusion of Tocilizumab and sport intervention

Treatment:

Drug: Tocilizumab

Behavioral: Sport

Sitagliptin

Active Comparator group

Description:

Intake of Sitagliptin and sport intervention

Treatment:

Drug: Sitagliptin

Behavioral: Sport

Placebo

Placebo Comparator group

Description:

Intake of placebo and sport intervention

Treatment:

Behavioral: Sport