Diabetes MellitusCATERINGNCT01333774
Influence of Different Approaches to Dietary Advising on the Effects of Acarbose Treatment in Obese Diabetic Patients Under Real-life Setting
An observational study of Diabetes Mellitus, run by Bayer at 1 site in Poland.
Trial summary
It has been recently suggested, that not the diet by itself, but also patient's adherence to dietary recommendations and all actions performed to improve dietary compliance, may be a significant factor influencing blood glucose control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Glucobay (Acarbose, BAYG5421)
- Type of treatment
- Pill or oral medicine
- How many people
- 423 participants
- Where
- 1 sitePoland
- Study dates
- May 2008to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic diabetic patients not treated with acarbose for approx. 3 mths.
Who may be able to join
- type 2 diabetes
- age>18 years
Who cannot join
- Hypersensitivity to acarbose or any of the excipients
- age<18
- 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 post-prandial filling of the stomach] and larger hernias)
- hepatic and severe renal impairment (creatinine clearance <25 mL/min/ 1,73m2)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compliance With Dietary Recommendations in Obese Diabetic Patients Undergoing Acarbose Therapy
It has been recently suggested, that not the diet by itself, but also patient's adherence to dietary recommendations and all actions performed to improve dietary compliance, may be a significant factor influencing blood glucose control. There are no clinical data on the influence of different approaches to dietary advising on the effects of acarbose treatment in obese diabetic patients under real-life setting in Poland. Thus, the aim of this study was to assess the influence of different approaches to dietary advisory on the effects of acarbose treatment (reflected by changes in HbA1c) in obese DM patients. We also intended to assess the influence of different approaches to dietary advising on the appearance of potential adverse events in acarbose treated obese DM patients.
- Conditions
- Diabetes Mellitus
- Being tested
- Glucobay (Acarbose, BAYG5421)
- Keywords
- Diabetes, Acarbose, Diet, Compliance, Advising
- Medical subject headings
- Diabetes Mellitus, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucobay (Acarbose, BAYG5421)Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Glucobay (Acarbose, BAYG5421) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c value between initial and final visit
Measured: approx. 3 mths after acarbose treatment initiation
Secondary outcomes (1)
Number of participants with adverse events in both study groups. The influence of different approaches to dietary advising on the appearance of adverse events.
Measured: approx 3 mths after acarbose treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startMay 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 423 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333774
- Sponsor's protocol ID
- 13928
- Other IDs
- GB0810PL
- Acronym
- CATERING
- Status last verified
- May 2012
- First submitted
- 4 Apr 2011
- Last updated
- 4 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance With Dietary Recommendations in Obese Diabetic Patients Undergoing Acarbose Therapy
- ClinicalTrials.gov ID
- NCT01333774
- Acronym / sponsor ID
- CATERING / 13928
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes, Acarbose, Diet, Compliance, Advising
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 12 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It has been recently suggested, that not the diet by itself, but also patient's adherence to dietary recommendations and all actions performed to improve dietary compliance, may be a significant factor influencing blood glucose control. There are no clinical data on the influence of different approaches to dietary advising on the effects of acarbose treatment in obese diabetic patients under real-life setting in Poland. Thus, the aim of this study was to assess the influence of different approaches to dietary advisory on the effects of acarbose treatment (reflected by changes in HbA1c) in obese DM patients. We also intended to assess the influence of different approaches to dietary advising on the appearance of potential adverse events in acarbose treated obese DM patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Glucobay (Acarbose, BAYG5421) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic diabetic patients not treated with acarbose for approx. 3 mths.
Key inclusion criteria (2 listed)
- type 2 diabetes
- age>18 years
Key exclusion criteria (7 listed)
- Hypersensitivity to acarbose or any of the excipients
- age<18
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucobay (Acarbose, BAYG5421)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 | Drug | Group 1 |
Primary outcome
Change in HbA1c value between initial and final visit
Time frame: approx. 3 mths after acarbose treatment initiation
1 secondary outcome
Number of participants with adverse events in both study groups. The influence of different approaches to dietary advising on the appearance of adverse events.
Time frame: approx 3 mths after acarbose treatment initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Bayer at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c value between initial and final visit (time frame: approx. 3 mths after acarbose treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2012.