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

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

    • Saitama
      • Kawagoe, Saitama, Japan, 350-8550
        • Department of Diabetes and Endocrinology, Saitama Medical Center, Saitama Medical University

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
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).
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.

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

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.

Clinical Trials on Type 2 Diabetes Mellitus

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