Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Andreas F. H. Pfeiffer

ORCID ID

Contact details

German Institute of Human Nutrition Potsdam
Arthur-Scheunert-Allee 114-116
Nuthetal
14458
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BfArM N: 4022119

Study information

Scientific title

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

Acronym

Acarbose-Adiponectin Study

Study hypothesis

We aimed to investigate whether a decreased postprandial glucose excursion and portal concentration of insulin by acarbose may improve insulin sensitivity (whole body and local, hepatic insulin sensitivity) and influence the circulating adiponectin levels (as other insulin sensitivity and cardiovascular disease [CVD] markers) in the subjects with different stages of glucose tolerance.

Ethics approval

1. Ethical Committee of Potsdam University approved on the 28th January 2004 (ref: N 9/17)
2. Ethical Committee of Brandenburg approved on the 10th March 2004 (ref: N AS-43/2004)

Study design

Single centre double-blind randomised placebo controlled 2 x 12 weeks cross-over study with a washout period of 12 weeks

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Metabolic syndrome and associated diseases

Intervention

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 consisted of acarbose 100 mg with three main meals and placebo taking three times per day. The total study duration including the wash-out phase was 40 weeks. Patients underwent liquid meal challenges and hyperinsulinemic, euglycemic glucose clamp at weeks 0, 12, 24 and 36.

Intervention type

Drug

Phase

Not Applicable

Drug names

Acarbose

Primary outcome measures

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 outcome measures

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).

Overall trial start date

02/04/2002

Overall trial end date

01/04/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

70 randomised patients

Participant 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

Recruitment start date

02/04/2002

Recruitment end date

01/04/2009

Locations

Countries of recruitment

Germany

Trial participating centre

German Institute of Human Nutrition Potsdam
Nuthetal
14458
Germany

Sponsor information

Organisation

Bayer Schering Pharma AG (Germany)

Sponsor details

c/o Dr. Peter Marx
Global Scientific Affairs Manager CVRM
Müllerstraße 170
Berlin
13353
Germany

Sponsor type

Industry

Website

http://www.bayerhealthcare.com/scripts/pages/de/index.php

Funders

Funder type

Government

Funder name

Federal Ministry for Education and Research (Bundeministerium für Bildung und Forschung [BMBF]) (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Firma Bayer Vital (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Firma BRAHMS AG (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22990716

Publication citations

  1. Results

    Rudovich N, Pivovarova O, Traberth A, Sparwasser A, Weickert MO, Bernigau W, Birkenfeld AL, Arafat AM, Bergmann A, Pfeiffer AF, Acarbose treatment enhances mid-regional pro-atrial natriuretic peptide concentrations in non-diabetic individuals: further evidence for a common cardiometabolic pathway?, Diabetologia, 2012, 55, 12, 3392-3395, doi: 10.1007/s00125-012-2724-9.

Editorial Notes