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 designSingle centre double-blind randomised placebo controlled 2 x 12 weeks cross-over study with a washout period of 12 weeks
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleSingle 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 acronymAcarbose-Adiponectin Study
Study objectivesWe 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) studiedMetabolic syndrome and associated diseases
InterventionEligible 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Acarbose
Primary outcome measureTo 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 measures1. 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 date02/04/2002
Completion date01/04/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants70 randomised patients
Key inclusion criteria1. 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 criteria1. 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 enrolment02/04/2002
Date of final enrolment01/04/2009

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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