Diabetes Mellitus Type 2NCT01315808
Rate of Change of HbA1c (dx/dt) May Predict Progression to Type 2 DM
An observational study of Diabetes Mellitus Type 2, run by Wyckoff Heights Medical Center at 1 site in United States.
Trial summary
The investigators hypothesize that the HbA1c shows a rising trend in pre-diabetics and normal population with risk factors of developing type 2 DM. There is no known diabetes model for predicting incident diabetes in an individual which takes into account the rate of change of HbA1c (dx/dt). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- How many people
- 542 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Sep 2012
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will recruit 1000 non-diabetes people those having at least one diabetes prone risk factor.
Who may be able to join
- No self-reported history of diabetes or pre-diabetes defined as per ADA criteria
- Age greater than 18 years
- Scheduled to receive HbA1c in participating clinic
- Able and willing to give legally effective consent
- Able and willing to participate in patient questionnaires(attached)
Who cannot join
- Previously or currently taking medications for lowering glucose (i.e., exenatide, pramlintide, metformin, rosiglitazone, pioglitazone, or future diabetes drugs) based on self-report and/or prescreening. Patients on drugs causing hyperglycemia like Oral Steroids will be excluded.
- Baseline HbA1c level above 5.7
- Severe Anemia (defined as Hb less than 8gm/dL)
- Patients with hemoglobinopathies
- Pregnancy
- Polycystic ovarian disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Wyckoff Heights Medical Center
Brooklyn, New York, 11237
About this study
Official title: Rate of Change of HbA1c (dx/dt) May Predict Progression to Type 2 DM: Comparing the Concept of dx/dt With QD Diabetes Prediction Model. D.E.R.M.S Initiative (Doctor Enabled Risk Management System)
The investigators hypothesize that the HbA1c shows a rising trend in pre-diabetics and normal population with risk factors of developing type 2 DM. There is no known diabetes model for predicting incident diabetes in an individual which takes into account the rate of change of HbA1c (dx/dt). In such cases, the rate of change of HbA1c may give the physicians lead time needed to implement the Diabetes Prevention Program measures.
- Conditions
- Diabetes Mellitus Type 2
- Medical subject headings
- Diabetes Mellitus, Type 2
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 |
|---|---|---|
| Low risk group | Patients will be stratified based on risk factors significantly contributing to diabetes type 2. | |
| Intermediate risk group | Not described | |
| High risk group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the rate of change of HbA1c in normal population with known risk factors of diabetes
Measured: one year
Secondary outcomes (1)
Diabetes prediction model based on the rate of change in HbA1c
To develop a mathematical model which will predict the onset of type 2 dm based on the rate of change in HbA1c valued leading to development of pre-diabetes
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJul 2012 (estimated)
- Study completionSep 2012 (estimated)
Why it stopped: Due to lack of funds to continue this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 542 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyckoff Heights Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Rekha Bhandari, MD, Principal investigator, Wyckoff Heights Medical Center, Brooklyn New YorkShitij Arora, MD, Principal investigator, Wyckoff Heights Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315808
- Sponsor's protocol ID
- whmc1
- Status last verified
- Mar 2012
- First submitted
- 14 Mar 2011
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rate of Change of HbA1c (dx/dt) May Predict Progression to Type 2 DM: Comparing the Concept of dx/dt With QD Diabetes Prediction Model. D.E.R.M.S Initiative (Doctor Enabled Risk Management System)
- ClinicalTrials.gov ID
- NCT01315808
- Acronym / sponsor ID
- whmc1
- Conditions
- Diabetes Mellitus Type 2
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to lack of funds to continue this study.
- Enrolment
- 542 participants (actual)
- Lead sponsor
- Wyckoff Heights Medical CenterUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 15 Mar 2011 (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.
The investigators hypothesize that the HbA1c shows a rising trend in pre-diabetics and normal population with risk factors of developing type 2 DM. There is no known diabetes model for predicting incident diabetes in an individual which takes into account the rate of change of HbA1c (dx/dt). In such cases, the rate of change of HbA1c may give the physicians lead time needed to implement the Diabetes Prevention Program measures.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low risk group | – | –Patients will be stratified based on risk factors significantly contributing to diabetes type 2. |
| Intermediate risk group | – | – |
| High risk group | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will recruit 1000 non-diabetes people those having at least one diabetes prone risk factor.
Key inclusion criteria (5 listed)
- No self-reported history of diabetes or pre-diabetes defined as per ADA criteria
- Age greater than 18 years
- Scheduled to receive HbA1c in participating clinic
- Able and willing to give legally effective consent
- Able and willing to participate in patient questionnaires(attached)
Key exclusion criteria (6 listed)
- Previously or currently taking medications for lowering glucose (i.e., exenatide, pramlintide, metformin, rosiglitazone, pioglitazone, or future diabetes drugs) based on self-report and/or prescreening. Patients on drugs causing hyperglycemia like Oral Steroids will be excluded.
- Baseline HbA1c level above 5.7
- Severe Anemia (defined as Hb less than 8gm/dL)
- Patients with hemoglobinopathies
- Pregnancy
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
Study the rate of change of HbA1c in normal population with known risk factors of diabetes
Time frame: one year
1 secondary outcome
Diabetes prediction model based on the rate of change in HbA1c
Time frame: one year
Results and safety
The study was stopped early (reason given: Due to lack of funds to continue this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2012.
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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.
Rekha Bhandari, MD principal investigator
Wyckoff Heights Medical Center, Brooklyn New York
Shitij Arora, MD principal investigator
Wyckoff Heights Medical Center
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 Diabetes Mellitus Type 2, run by Wyckoff Heights Medical Center at 1 site in United States.
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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 20 Mar 2012. 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 United States. 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 was stopped early (reason given: Due to lack of funds to continue this study.). Results are not available in the source record.
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.
What does the primary outcome measure?
Study the rate of change of HbA1c in normal population with known risk factors of diabetes (time frame: one year). It is what the study was designed to measure, not a finding.
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 20 Mar 2012; AzTrials last refreshed its copy on 8 Nov 2026.