Exercise and Acarbose in Type 2 Diabetes

Karolinska Institute

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: Acarbose; Behavioral: Exercise; Other: Exercise + Acarbose

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01244971

DNR 03-539

Details and patient eligibility

About

The purpose of this study is to investigate the impact of exercise training, Acarbose, and the combination of exercise and Acarbose on glycemic control, body composition, insulin sensitivity and other cardiovascular risk markers in type 2 diabetes. Further, muscle biopsies will be obtain to study gene expression. Our hypothesis is that the combination therapy will be superior to monotherapy with exercise or Acarbose.

Enrollment: 62 patients

Sex: All

Ages: 45 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Men and women, diagnosis of type 2 diabetes established since at least three months, treatment with diet or maximum one oral anti-diabetic drug, GHb < 8.5 %, age 45 - 60 years, BMI 25 - 30 kg/m2, no participation in any regular exercise program.

Exclusion Criteria: Unable to perform exercise, significant GI-disease, severe heart-disease, renal failure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

62 participants in 3 patient groups

Acarbose

Active Comparator group

Treatment:

Drug: Acarbose

Exercise

Active Comparator group

Treatment:

Behavioral: Exercise

Exercise + Acarbose

Experimental group

Treatment:

Other: Exercise + Acarbose