Type 2 DiabetesNCT01379690
Retrospective Study: Hip Fractures in Diabetic Patients
An observational study of Type 2 Diabetes and Hip Fractures, run by Changi General Hospital at 1 site in Singapore.
Trial summary
Type 2 DM patients are at increased risk of falls as a consequence of long term hyperglycemic complications including retinopathy and neuropathy, and also as a result of hypoglycaemic therapy. Values of A1C <= 7% has been shown to increase the risk of falls in elderly T2DM patients . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 2 Diabetes, Hip Fractures
- What is being tested?
- HBA1C
- How many people
- 1,162 participants
- Where
- 1 siteSingapore
- Study dates
- Apr 2011to Jun 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All diabetic patients on treatment with medications, seen at Changi General Hospital from 2005-2010
Who may be able to join
- Type 2 Diabetic Patients
- Hip fracture (Case) or no hip fracture (control)
Who cannot join
- Traumatic fractures
- on diet control for diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of HBA1C and Hip Fractures in Elderly Type 2 Diabetic Patients
Type 2 DM patients are at increased risk of falls as a consequence of long term hyperglycemic complications including retinopathy and neuropathy, and also as a result of hypoglycaemic therapy. Values of A1C <= 7% has been shown to increase the risk of falls in elderly T2DM patients .
Increased fall risk may explain why T2DM patients are at increased risk of hip fractures , despite having a higher bone mineral density as compared to non-T2DM patients. Given the high morbidity and mortality (25% mortality in 1st year post-fracture) associated with hip fractures , all care must be given to prevent hip fractures in T2DM patients.
Read more
There is controversial data on T2DM medications and fracture risk. Vestergaard showed that use of metformin and sulphonylureas decreased the risk of all fractures, while there was there was a similar trend with insulin.
The present study sought to evaluate the relationship between A1c values and the risk of fractures in treated patients with T2DM.
Read the detailed description
This was a retrospective case-control study. All patients with T2DM admitted with a primary diagnosis of hip fracture and a A1c performed within 3 months of the event admitted to Changi General Hospital, Singapore from 1st Jan 2005 to 31st Dec 2010were included in the study. As the present study was targeted at looking at an association between the glucose lowering effect of medications on A1C levels and subsequent hip fracture risk, exclusion criteria included patients who wereduplicate cases, traumatic fractures, newly diagnosed T2DM patients, and those on diet control.
The information on discharge diagnosis was taken from the Discharge Register of the Hospital. It includes all diagnosis of the patient upon discharge. The diagnosis of patients is coded using the International Classification of Diseases (ICD) system. All patients admitted with the diagnosis of neck of femur fracture (8208 ICD-9), inter-trochanteric fracture (82021 ICD-9), sub-trochanteric fracture (82022 ICD-9), transcervical fracture (82003 ICD-9), and a secondary diagnosis of diabetes (250 ICD-9) were identified from the register.
Out of 932 patients initially identified, 31 were duplicates, 10 were admitted for a traumatic fracture, 136 had no recent A1C level. Of the remaining 757 patients, 162 on diet control and 12 newly diagnosed with diabetes were excluded. The final list of cases consisted of 581 patients, 157 men and 427 women, mean age 76.3 ± 8.7 years.
Controls were selected from a register of patients managed for diabetes from a similar period (1st Jan 2005 to 31st Dec 2010) at Changi General Hospital outpatient clinics (N=4,522). For each case, one control subject, matched for sex and within 2 years of age, was randomly selected from the register. Inclusion criteria included patients taking oral hypoglycemic agents or insulin, and exclusion criteria were patients with a history of hip fractures.
Information on the baseline characteristics and exposure variables were collected by the same methods in cases and control subjects, using the computerised medical records and discernment of the medical notes.
The study was performed in accordance with the Declaration of Helsinki.
- Conditions
- Type 2 Diabetes, Hip Fractures
- Being tested
- HBA1C
- Keywords
- HbA1c
- Medical subject headings
- Diabetes Mellitus, Type 2, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBA1COther
Used level of HBA1C as a reflection of glycaemic control of the cases and controls
| Study group | Role | What they receive |
|---|---|---|
| Control | Controls were selected from patients with diabetes on consultation during the year 2005-2010 in specialist clinic, without a previous hip fracture. There was no followup period for these patients. Instead the A1C value upon the point of consultation was used to reflect glycaemic control at the point of consultation Receives: Other: HBA1C | |
| Case | All patients with treated diabetes admitted with primary diagnosis hip fractures from 2005-2010 to Changi General Hospital was included in the study. The A1C at the point of admission was used to reflect the glycaemic control at that point in time. This was a retrospective study and there was no subsequent follow up on patients after the point of admission Receives: Other: HBA1C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip Fracture
Admission for hip fracture
Measured: 2005-2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 1,162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Puar Hai Kiat Troy, Changi General Hospital
- Investigators
- Troy H Puar, MRCP, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379690
- Sponsor's protocol ID
- ChangiGH
- Status last verified
- Feb 2012
- First submitted
- 22 Jun 2011
- Last updated
- 23 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Vestergaard P, Rejnmark L, Mosekilde L. Relative fracture risk in patients with diabetes mellitus, and the impact of insulin and oral antidiabetic medication on relative fracture risk. Diabetologia. 2005 Jul;48(7):1292-9. doi: 10.1007/s00125-005-1786-3. Epub 2005 May 21.
PubMed 15909154
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of HBA1C and Hip Fractures in Elderly Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT01379690
- Acronym / sponsor ID
- ChangiGH
- Conditions
- Type 2 Diabetes, Hip Fractures
- Keywords
- HbA1c
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,162 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 23 Jun 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.
Type 2 DM patients are at increased risk of falls as a consequence of long term hyperglycemic complications including retinopathy and neuropathy, and also as a result of hypoglycaemic therapy. Values of A1C <= 7% has been shown to increase the risk of falls in elderly T2DM patients .
Increased fall risk may explain why T2DM patients are at increased risk of hip fractures , despite having a higher bone mineral density as compared to non-T2DM patients. Given the high morbidity and mortality (25% mortality in 1st year post-fracture) associated with hip fractures , all care must be given to prevent hip fractures in T2DM patients.
There is controversial data on T2DM medications and fracture risk. Vestergaard showed that use of metformin and sulphonylureas decreased the risk of all fractures, while there was there was a similar trend with insulin.
The present study sought to evaluate the relationship between A1c values and the risk of fractures in treated patients with T2DM.
Detailed description
This was a retrospective case-control study. All patients with T2DM admitted with a primary diagnosis of hip fracture and a A1c performed within 3 months of the event admitted to Changi General Hospital, Singapore from 1st Jan 2005 to 31st Dec 2010were included in the study. As the present study was targeted at looking at an association between the glucose lowering effect of medications on A1C levels and subsequent hip fracture risk, exclusion criteria included patients who wereduplicate cases, traumatic fractures, newly diagnosed T2DM patients, and those on diet control.
The information on discharge diagnosis was taken from the Discharge Register of the Hospital. It includes all diagnosis of the patient upon discharge. The diagnosis of patients is coded using the International Classification of Diseases (ICD) system. All patients admitted with the diagnosis of neck of femur fracture (8208 ICD-9), inter-trochanteric fracture (82021 ICD-9), sub-trochanteric fracture (82022 ICD-9), transcervical fracture (82003 ICD-9), and a secondary diagnosis of diabetes (250 ICD-9) were identified from the register.
Out of 932 patients initially identified, 31 were duplicates, 10 were admitted for a traumatic fracture, 136 had no recent A1C level. Of the remaining 757 patients, 162 on diet control and 12 newly diagnosed with diabetes were excluded. The final list of cases consisted of 581 patients, 157 men and 427 women, mean age 76.3 ± 8.7 years.
Controls were selected from a register of patients managed for diabetes from a similar period (1st Jan 2005 to 31st Dec 2010) at Changi General Hospital outpatient clinics (N=4,522). For each case, one control subject, matched for sex and within 2 years of age, was randomly selected from the register. Inclusion criteria included patients taking oral hypoglycemic agents or insulin, and exclusion criteria were patients with a history of hip fractures.
Information on the baseline characteristics and exposure variables were collected by the same methods in cases and control subjects, using the computerised medical records and discernment of the medical notes.
The study was performed in accordance with the Declaration of Helsinki.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: HBA1CControls were selected from patients with diabetes on consultation during the year 2005-2010 in specialist clinic, without a previous hip fracture. There was no followup period for these patients. Instead the A1C value upon the point of consultation was used to reflect glycaemic control at the point of consultation |
| Case | – | Other: HBA1CAll patients with treated diabetes admitted with primary diagnosis hip fractures from 2005-2010 to Changi General Hospital was included in the study. The A1C at the point of admission was used to reflect the glycaemic control at that point in time. This was a retrospective study and there was no subsequent follow up on patients after the point of admission |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All diabetic patients on treatment with medications, seen at Changi General Hospital from 2005-2010
Key inclusion criteria (2 listed)
- Type 2 Diabetic Patients
- Hip fracture (Case) or no hip fracture (control)
Key exclusion criteria (2 listed)
- Traumatic fractures
- on diet control for diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBA1CUsed level of HBA1C as a reflection of glycaemic control of the cases and controls | Other | Case, Control |
Primary outcome
Hip Fracture
Time frame: 2005-2010
Admission for hip fracture
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 23 Feb 2012.
- Background: PubMed 15909154Vestergaard P, Rejnmark L, Mosekilde L. Relative fracture risk in patients with diabetes mellitus, and the impact of insulin and oral antidiabetic medication on relative fracture risk. Diabetologia. 2005 Jul;48(7):1292-9. doi: 10.1007/s00125-005-1786-3. Epub 2005 May 21.
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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.
Troy H Puar, MRCP principal investigator
Changi General Hospital
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 and Hip Fractures, run by Changi General Hospital at 1 site in Singapore.
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 23 Feb 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 Singapore. 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.
What does the primary outcome measure?
Hip Fracture (time frame: 2005-2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01379690, which also lists 1 linked publication.
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 23 Feb 2012.