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Relationship Between Body Weight and Glycohemoglobin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00892372
First Posted: May 4, 2009
Last Update Posted: May 4, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Saitama Medical University
  Purpose
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.

Condition
Type 2 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Relationship Between Changes in Body Weight and Glycohemoglobin Levels in Patients With Type 2 Diabetes Treated With Diet or Pioglitazone.

Resource links provided by NLM:


Further study details as provided by Saitama Medical University:

Enrollment: 100
Study Start Date: April 2009
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

  Eligibility

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Ages Eligible for Study:   32 Years to 76 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
primary care clinic
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00892372


Locations
Japan
Department of Diabetes and Endocrinology, Saitama Medical Center, Saitama Medical University
Kawagoe, Saitama, Japan, 350-8550
Sponsors and Collaborators
Saitama Medical University
Investigators
Principal Investigator: Eiji Ohmura, M.D. Department of Diabetes and Endocrinology, Saitama Medical Center, Saitama Medical University
  More Information

Responsible Party: Eiji Ohmura/ M.D., Saitama Medical center, Saitama Medical University
ClinicalTrials.gov Identifier: NCT00892372     History of Changes
Other Study ID Numbers: bwhba1c
First Submitted: May 1, 2009
First Posted: May 4, 2009
Last Update Posted: May 4, 2009
Last Verified: May 2009

Keywords provided by Saitama Medical University:
body weight
glycohemoglobin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Body Weight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Signs and Symptoms
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs