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 |
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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
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 |
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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 |
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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
14458
Germany
Sponsor information
Bayer Schering Pharma AG (Germany)
Industry
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 |
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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 | |
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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? |
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Results article | results | 01/12/2012 | Yes | No |