Relationship Between Body Weight and Glycohemoglobin

This study has been completed.
Sponsor:
Information provided by:
Saitama Medical University
ClinicalTrials.gov Identifier:
NCT00892372
First received: May 1, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  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

Ages Eligible for Study:   32 Years to 76 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Eiji Ohmura/ M.D., Saitama Medical center, Saitama Medical University
ClinicalTrials.gov Identifier: NCT00892372     History of Changes
Other Study ID Numbers: bwhba1c
Study First Received: May 1, 2009
Last Updated: May 1, 2009
Health Authority: Japan: Institutional Review Board

Keywords provided by Saitama Medical University:
body weight
glycohemoglobin

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

ClinicalTrials.gov processed this record on August 18, 2014