Investigation of the effects of postprandial glucose reduction by acarbose on insulin sensitivity and cardio-vascular markers in the subjects with different stages of glucose tolerance

Single centre, double-blind, randomised, placebo controlled, cross-over study to investigate the effects of postprandial glucose reduction by acarbose on insulin sensitivity and cardio-vascular markers in type 2 diabetes patients, subjects with impaired glucose tolerance and normal glucose tolerant subjects

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN40281673

Enrollment

Registered

2010-06-29

Start date

2002-04-02

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic syndrome and associated diseases Nutritional, Metabolic, Endocrine Metabolic syndrome

Interventions

Eligible patients who completed a 3-week run-in period (first wash-out phase), were randomised into two treatment sequences to receive 12 weeks of double-blind treatment. Both treatment sequences cons

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Males or females, aged between 18 and 75 years inclusive 2. Newly diagnosed type 2 diabetes, or previously treated with diet and/or exercise or treated with metformin or acarbose as monotherapy or with impaired glucose tolerance (IGT)/impaired fasting glucose (IFG) or with normal glucose tolerance 3. Female patients were either non-fertile or willing to use a medically approved birth control method during the whole duration of the study 4. Body mass index (BMI) between 20 and 40 kg/m^2 5. Fasting plasma glucose (FPG) less than 15 mmol/1 6. Fasting C-peptide greater than 1 ng/ml

Exclusion criteria

Exclusion criteria: 1. On treatment with insulin, insulin secretagogues, corticosteroids (with the exception of inhaled corticosteroids), thiazolidindiones derivates and monoaminooxidase inhibitors 2. Known sensitivity to drugs similar to acarbose 3. Serum creatinine greater than 1.5 mg/dl or pre-existing end-stage nephropathy 4. On laser treatment for diabetes related retinopathy within 3 months prior to study start 5. Alanine aminotransferase (ALAT) greater than 2.5 times of normal range 6. Type 1 diabetes mellitus 7. Thyroid stimulating hormone (TSH) outside of normal range 8. Medical history or signs of chronically gastrointestinal diseases with diarrhoea, flatulence and absorption anomalies

Design outcomes

Primary

Measure	Time frame
To assess the effect of postprandial glucose reduction by acarbose on insulin sensitivity in subjects with different stages of glucose tolerance. Measured at the start and at the end of each treatments (12 week duration).	—

Secondary

Measure	Time frame
1. To assess the effects of acarbose on fasting cytokines and on postprandial glucose and insulin metabolism 2. To assess the effects on liver fat content and CVD markers Measured at the start and at the end of each treatments (12 week duration).	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026