Type 2 Diabetes MellitusNCT00892372
Relationship Between Body Weight and Glycohemoglobin
An observational study of Type 2 Diabetes Mellitus, run by Saitama Medical University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 32 to 76 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2009to Apr 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- type 2 diabetes under reasonable glycemic control (HbA1c; less than around 7%)
- type 2 diabetic patients treated with the diet therapy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Diabetes and Endocrinology, Saitama Medical Center, Saitama Medical University
Kawagoe, Saitama, 350-8550
About this study
Official title: 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.
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- body weight, glycohemoglobin
- Medical subject headings
- Diabetes Mellitus, Type 2, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saitama Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Eiji Ohmura, M.D., Principal investigator, Department of Diabetes and Endocrinology, Saitama Medical Center, Saitama Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00892372
- Sponsor's protocol ID
- bwhba1c
- Status last verified
- May 2009
- First submitted
- 1 May 2009
- Last updated
- 4 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Changes in Body Weight and Glycohemoglobin Levels in Patients With Type 2 Diabetes Treated With Diet or Pioglitazone.
- ClinicalTrials.gov ID
- NCT00892372
- Acronym / sponsor ID
- bwhba1c
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- body weight, glycohemoglobin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Saitama Medical UniversityUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 4 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 32 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (2 listed)
- type 2 diabetes under reasonable glycemic control (HbA1c; less than around 7%)
- type 2 diabetic patients treated with the diet therapy
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eiji Ohmura, M.D. principal investigator
Department of Diabetes and Endocrinology, Saitama Medical Center, Saitama Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, run by Saitama Medical University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2009.