NCT00892372

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 1, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2009

Completed
Last Updated

May 4, 2009

Status Verified

May 1, 2009

Enrollment Period

Same day

First QC Date

May 1, 2009

Last Update Submit

May 1, 2009

Conditions

Keywords

body weightglycohemoglobin

Study Arms (2)

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 Criteria

Age32 Years - 76 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

primary care clinic

You may qualify if:

  • type 2 diabetes under reasonable glycemic control (HbA1c; less than around 7%)
  • type 2 diabetic patients treated with the diet therapy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Diabetes and Endocrinology, Saitama Medical Center, Saitama Medical University

Kawagoe, Saitama, 350-8550, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Body Weight

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eiji Ohmura, M.D.

    Department of Diabetes and Endocrinology, Saitama Medical Center, Saitama Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 1, 2009

First Posted

May 4, 2009

Study Start

April 1, 2009

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

May 4, 2009

Record last verified: 2009-05

Locations