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ISRCTN
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ISRCTN40281673
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DOI
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10.1186/ISRCTN40281673
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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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
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Scientific title
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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
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Acronym
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Acarbose-Adiponectin Study
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Serial number at source
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BfArM N: 4022119
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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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)
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Study design
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Single centre double-blind randomised placebo controlled 2 x 12 weeks cross-over study with a washout period of 12 weeks
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Metabolic syndrome and associated diseases
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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02/04/2002
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Anticipated end date
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01/04/2009
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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70 randomised patients
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Interventions
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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.
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Primary outcome measure(s)
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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).
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Secondary outcome measure(s)
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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).
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Sources of funding
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1. Federal Ministry for Education and Research (Bundeministerium für Bildung und Forschung [BMBF]) (Germany)
2. Firma Bayer Vital (Germany)
3. Firma BRAHMS AG (Germany)
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Trial website
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Publications
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Contact name
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Prof
Andreas F. H.
Pfeiffer
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Address
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German Institute of Human Nutrition Potsdam
Arthur-Scheunert-Allee 114-116
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City/town
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Nuthetal
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Zip/Postcode
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14458
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Country
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Germany
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Sponsor
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Bayer Schering Pharma AG (Germany)
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Address
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c/o Dr. Peter Marx
Global Scientific Affairs Manager CVRM
Müllerstraße 170
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City/town
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Berlin
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Zip/Postcode
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13353
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Country
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Germany
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Sponsor website:
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http://www.bayerhealthcare.com/scripts/pages/de/index.php
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Date applied
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11/06/2010
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Last edited
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29/06/2010
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Date ISRCTN assigned
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29/06/2010
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