- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00892372
Relationship Between Body Weight and Glycohemoglobin
May 1, 2009 updated by: Saitama Medical University
Relationship Between Changes in Body Weight and Glycohemoglobin Levels in Patients With Type 2 Diabetes Treated With Diet or Pioglitazone.
Control of body weight (BW) is important to prevent and manage type 2 diabetes.
Regardless of the close association, little is understood about the precise relationship between BW and glycemic control, which might be of benefit for patients with type 2 diabetes.
The researchers investigated the correlation between changes in BW and glycemic control in patients with type 2 diabetes treated with a diet therapy or pioglitazone.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Saitama
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Kawagoe, Saitama, Japan, 350-8550
- Department of Diabetes and Endocrinology, Saitama Medical Center, Saitama Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
32 years to 76 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
primary care clinic
Description
Inclusion Criteria:
- type 2 diabetes under reasonable glycemic control (HbA1c; less than around 7%)
- type 2 diabetic patients treated with the diet therapy
Exclusion Criteria:
- type 2 diabetic patients with edema, severe liver dysfunction, renal dysfunction, moderate to severe anemia or congestive heart failure
- type 2 diabetic patients treated with insulin therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1 (type 2 diabetes, body weight, HbA1c)
The investigators analyzed the recorded data (body weight and glycohemoglobin) of 70 type 2 diabetic patients treated with the diet therapy.
Recorded values at 0, 2 and 4 months for body weight (BW) and glycohemoglobin (HbA1c) were used.
And changes from baseline (0 month) in BW (ΔBW) were plotted against those of HbA1c (ΔHbA1c).
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2 (type 2 diabetes, pioglitazone, HbA1c)
The investigators analyzed the recorded data (body weight and glycohemoglobin) of 23 type 2 diabetic patients treated with pioglitazone.
Recorded values at 0, 2 and 4 months for body weight (BW)and glycohemoglobin (HbA1c) were used.
And changes from baseline (0 month) in BW (ΔBW) were plotted against those of HbA1c (ΔHbA1c).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eiji Ohmura, M.D., Department of Diabetes and Endocrinology, Saitama Medical Center, Saitama Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
May 1, 2009
First Submitted That Met QC Criteria
May 1, 2009
First Posted (Estimate)
May 4, 2009
Study Record Updates
Last Update Posted (Estimate)
May 4, 2009
Last Update Submitted That Met QC Criteria
May 1, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- bwhba1c
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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