Prevention of Postprandial Hyperglycemia by Acarbose May be a Promising Therapeutic Strategy for Reducing the Increased Risk for Cardiovascular Disease
ABDOMEN
Acarbose in Cardiovascular Risk Management. Assessment of Clinical Efficacy and Safety of Acarbose and Its Effect on Selected Cardiovascular Risk Factors in Type 2 Diabetes Patients.
2 other identifiers
observational
3,310
1 country
1
Brief Summary
The use of acarbose in impaired glucose tolerance (IGT) and type 2 diabetic subjects has been associated with a significant reduction of cardiovascular events. Additionally, acarbose has been shown to have a beneficial influence on some of the other cardiovascular risk factors (metabolic syndrome components). Thus, prevention of postprandial hyperglycemia by acarbose may be a promising therapeutic strategy for reducing the increased risk for cardiovascular disease. Further studies are needed to confirm the influence of acarbose on cardiovascular risk factors in the real life setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 16, 2010
CompletedFirst Posted
Study publicly available on registry
July 22, 2010
CompletedAugust 25, 2010
August 1, 2010
10 months
July 16, 2010
August 24, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety, tolerability of acarbose and its effect on body weight, waist circumference and blood pressure
approximately 6 months after acarbose treatment initiation
Secondary Outcomes (1)
Effect of acarbose on HbA1c, fasting and postprandial glycemia and on lipid profile
approximately 6 months after acarbose treatment initiation
Study Arms (1)
Group 1
Interventions
Patients treated with acarbose tablets under the real-life setting. Dosing regimen customised to the needs of each participating patient according to the investigators assessment
Eligibility Criteria
Primary care clinic diabetic patients not treated with acarbose for at least 3 months.
You may qualify if:
- Diabetes Mellitus
- Age \>/= 18 years
You may not qualify if:
- Hypersensitivity to acarbose or any of the excipients
- Age \<18 years
- Pregnancy and in nursing
- Inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or in patients predisposed to intestinal obstruction
- Chronic intestinal diseases associated with marked disorders of digestion or absorption
- States which may deteriorate as a result of increased gas formation in the intestine, (e.g. Roemheld's syndrome \[an angina pectoris-like syndrome or aggravation of an angina pectoris due to the postprandial filling of the stomach\] and larger hernias)
- Hepatic and severe renal impairment (creatinine clearance \<25 mL/min/ 1,73m2)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Unknown Facility
Many Locations, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 16, 2010
First Posted
July 22, 2010
Study Start
May 1, 2007
Primary Completion
March 1, 2008
Study Completion
June 1, 2008
Last Updated
August 25, 2010
Record last verified: 2010-08