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

ISRCTN	ISRCTN40281673
DOI	https://doi.org/10.1186/ISRCTN40281673
Secondary identifying numbers	BfArM N: 4022119

Submission date: 11/06/2010
Registration date: 29/06/2010
Last edited: 03/06/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Andreas F. H. Pfeiffer
Scientific

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

Study information

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
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	Acarbose-Adiponectin Study
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Acarbose
Primary outcome measure	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 study start date	02/04/2002
Completion date	01/04/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	70 randomised patients
Key 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
Key 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
Date of first enrolment	02/04/2002
Date of final enrolment	01/04/2009

Locations

Countries of recruitment

Germany

Study participating centre

German Institute of Human Nutrition Potsdam

Nuthetal
14458
Germany

Sponsor information

Bayer Schering Pharma AG (Germany)
Industry

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

Website	http://www.bayerhealthcare.com/scripts/pages/de/index.php
"ROR"	https://ror.org/04hmn8g73

Funders

Funder type

Government

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

No information available

Firma Bayer Vital (Germany)

No information available

Firma BRAHMS AG (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2012		Yes	No