Type 2 DiabetesNCT01282060
Association Between Glycaemic Control and Morbi/Mortality After 5 Years of Follow-up in Type 2 Diabetic Patients
An observational study of Type 2 Diabetes, run by Association Pour la Recherche en Diabetologie et en Geriatrie.
Trial summary
The purpose of this study is to asses the link between glycaemic balance (summarised by HBA1C LEVEL) and specific causes of death. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 986 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Sep 2021
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: * Patients suffering from type 2 diabetes and aged 70 and over. * Having received medicinal or non-medicinal therapy (in the case of diabetics treated with insulin, the lengh of time between diagnosis of diabtees and the introduction of insulin therapy is at least 6 months). * Suffering from type 2 diabetes at least one year. * With autonomy defined by a score greater than or equal to 3/6 on the ADL scale and able of being followed-up during hospital or private consultations over the next 5 years. * Patients who did not refuse to participate in the study after receiving information on the study (Patient Information Leaflet). The patient are monitored in the hospital or private sector throughout Metropolitan France.
Who may be able to join
- Patient with type 2 diabetes, aged 70 and over,
- Patient having received medicinal or non-medicinal treatment (in the case of diabetics treated with insulin, the length of time between diagnosis of diabetes and the onset of insulin therapy will be at least 2 years),
- Diabetes diagnosed for at least one year,
- Patient with autonomy defined by a score greater than or equal to 3/6 on the ADL scale,
- Patient who can be monitored during hospital or private consultations over the next 10 years,
- Patient who did not refuse to take part in the study after receiving information on the study (Patient Information Leaflet), Patients are monitored in the hospital or private sector throughout France.
Who cannot join
- Patient with type 1 diabetes,
- Patient with secondary diabetes (mainly corticosteroid-induced),
- Patient with a loss of autonomy defined by a score of less than 3/6 on the ADL scale,
- Patient who cannot be monitored in the months or years to come,
- Patient in an acute situation (transient exclusion criterion),
- Patient expressing their refusal to participate in the study.
About this study
The purpose of this study is to asses the link between glycaemic balance (summarised by HBA1C LEVEL) and specific causes of death.
Read the detailed description
The GERODIAB study is the first prospective, longitudinal follow-up cohort study, the main aim of which is to assess the link between glycaemic balance (evaluated on the basis of HbA1c levels) and total mortality at 5 years in diabetic patients aged 70 and over, and suffering from type 2 diabetes. An extension to 10 years is considered given the innovative features of this cohort follow-up procedure.
The secondary endpoints are as follows:
- To assess the link between glycaemic balance and the mortality rate with specific causes.
- To assess the link between glycaemic balance and the onset of or change in diabetes-related complications: cardiovascular diseases, change in renal function, diabetic retinopathy, peripheral neuropathy, perforating ulcer of the foot and acute metabolic complications.
- To assess the link between glycaemic balance and nutritional status, the onset of or changes in cognitive disorders and a loss of autonomy.
- To specify the role of other cardiovascular risk factors combined with glycaemic balance, in mortality, diabetes-related complications, cognitive disorders and loss of autonomy.
- Conditions
- Type 2 Diabetes
- Keywords
- HBA1C, DIABETES-RELATED COMPLICATIONS, GLYCAEMIC BALANCE
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Link between HbA1c level and the overall mortality rate at 5 years.
The primary endpoint is to assess the link between glycaemic balance (assessed on the basis of the HbA1c level) and the overall mortality rate at 5 years for patients of 70 and over suffering from type 2 diabetes.
Measured: 5 years
Secondary outcomes (6)
Link between HbA1c level and specific causes of death.
To assess the link between glycaemic balance (summarised by HbA1c level) and specific causes of death.
Measured: 5 years
Link between HbA1c level and the onset of or changes in diabetes-related complications
To assess the link between glycaemic balance (summarised by HbA1c) and the onset of or changes in diabetes-related complications: - cardiovascular diseases (coronary failure, heart failure, cerebrovascular accidents, arteriopathy obliterans of the lower limbs), - change in renal function, diabetic retinopathy, peripheral neuropathy, perforating ulcer of the foot, acute metabolic complications (hypoglycaemia, diabetic ketoacidosis, hyperosmolarity).
Measured: 5 years
Link between HbA1c level and nutritional status.
To assess the link between glycaemic balance and nutritional status.
Measured: 5 years
Link between HbA1c level and the onset of or changes in cognitive disorders.
To assess the link between glycaemic balance and the onset of or changes in cognitive disorders.
Measured: 5 years
Link between HbA1c level and loss of autonomy.
To assess the link between glycaemic balance and loss of autonomy.
Measured: 5 years
Role of other cardiovascular risk factors
To specify the role of other cardiovascular risk factors (primarily, arterial hypertension, dyslipidaemia and obesity) in association with glycaemic balance on the mortality rate, diabetes-related complications, cognitive disorders and loss of autonomy.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study startMar 2009
- Primary completionApr 2016
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 986 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association Pour la Recherche en Diabetologie et en Geriatrie
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S, Umanis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282060
- Sponsor's protocol ID
- CRO0662-1
- Status last verified
- Jan 2017
- First submitted
- 21 Jan 2011
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Doucet J, Verny C, Bordier L, Rekik A, Zulfiqar AA, Bezerra CB, Bauduceau B. Evolution in geriatric syndromes and association with survival over 5 years in the GERODIAB cohort of older French diabetic patients. Eur Geriatr Med. 2021 Jun;12(3):619-625. doi: 10.1007/s41999-020-00425-9. Epub 2020 Nov 22.
PubMed 33225383Doucet J, Verny C, Balkau B, Scheen AJ, Bauduceau B. Haemoglobin A1c and 5-year all-cause mortality in French type 2 diabetic patients aged 70 years and older: The GERODIAB observational cohort. Diabetes Metab. 2018 Dec;44(6):465-472. doi: 10.1016/j.diabet.2018.05.003. Epub 2018 May 18.
PubMed 29859993Bauduceau B, Le Floch JP, Halimi S, Verny C, Doucet J; SFD/SFGG Intergroup. Cardiovascular Complications Over 5 Years and Their Association With Survival in the GERODIAB Cohort of Elderly French Patients With Type 2 Diabetes. Diabetes Care. 2018 Jan;41(1):156-162. doi: 10.2337/dc17-1437. Epub 2017 Nov 7.
PubMed 29113984
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Glycaemic Control and Morbi/Mortality After 5 Years of Follow-up in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT01282060
- Acronym / sponsor ID
- CRO0662-1
- Conditions
- Type 2 Diabetes
- Keywords
- HBA1C, DIABETES-RELATED COMPLICATIONS, GLYCAEMIC BALANCE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 986 participants (actual)
- Lead sponsor
- Association Pour la Recherche en Diabetologie et en GeriatrieUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S, Umanis
- Study start
- Mar 2009
- Primary completion
- Apr 2016 (actual)
- Study completion
- Sep 2021 (estimated)
- First posted
- 24 Jan 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 purpose of this study is to asses the link between glycaemic balance (summarised by HBA1C LEVEL) and specific causes of death.
Detailed description
The GERODIAB study is the first prospective, longitudinal follow-up cohort study, the main aim of which is to assess the link between glycaemic balance (evaluated on the basis of HbA1c levels) and total mortality at 5 years in diabetic patients aged 70 and over, and suffering from type 2 diabetes. An extension to 10 years is considered given the innovative features of this cohort follow-up procedure.
The secondary endpoints are as follows:
- To assess the link between glycaemic balance and the mortality rate with specific causes.
- To assess the link between glycaemic balance and the onset of or change in diabetes-related complications: cardiovascular diseases, change in renal function, diabetic retinopathy, peripheral neuropathy, perforating ulcer of the foot and acute metabolic complications.
- To assess the link between glycaemic balance and nutritional status, the onset of or changes in cognitive disorders and a loss of autonomy.
- To specify the role of other cardiovascular risk factors combined with glycaemic balance, in mortality, diabetes-related complications, cognitive disorders and loss of autonomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- * Patients suffering from type 2 diabetes and aged 70 and over. * Having received medicinal or non-medicinal therapy (in the case of diabetics treated with insulin, the lengh of time between diagnosis of diabtees and the introduction of insulin therapy is at least 6 months). * Suffering from type 2 diabetes at least one year. * With autonomy defined by a score greater than or equal to 3/6 on the ADL scale and able of being followed-up during hospital or private consultations over the next 5 years. * Patients who did not refuse to participate in the study after receiving information on the study (Patient Information Leaflet). The patient are monitored in the hospital or private sector throughout Metropolitan France.
Key inclusion criteria (6 listed)
- Patient with type 2 diabetes, aged 70 and over,
- Patient having received medicinal or non-medicinal treatment (in the case of diabetics treated with insulin, the length of time between diagnosis of diabetes and the onset of insulin therapy will be at least 2 years),
- Diabetes diagnosed for at least one year,
- Patient with autonomy defined by a score greater than or equal to 3/6 on the ADL scale,
- Patient who can be monitored during hospital or private consultations over the next 10 years,
Key exclusion criteria (6 listed)
- Patient with type 1 diabetes,
- Patient with secondary diabetes (mainly corticosteroid-induced),
- Patient with a loss of autonomy defined by a score of less than 3/6 on the ADL scale,
- Patient who cannot be monitored in the months or years to come,
- Patient in an acute situation (transient exclusion criterion),
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
Link between HbA1c level and the overall mortality rate at 5 years.
Time frame: 5 years
The primary endpoint is to assess the link between glycaemic balance (assessed on the basis of the HbA1c level) and the overall mortality rate at 5 years for patients of 70 and over suffering from type 2 diabetes.
6 secondary outcomes
Link between HbA1c level and specific causes of death.
Time frame: 5 years
Link between HbA1c level and the onset of or changes in diabetes-related complications
Time frame: 5 years
Link between HbA1c level and nutritional status.
Time frame: 5 years
Link between HbA1c level and the onset of or changes in cognitive disorders.
Time frame: 5 years
Link between HbA1c level and loss of autonomy.
Time frame: 5 years
Role of other cardiovascular risk factors
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
- Derived from this study: PubMed 33225383Doucet J, Verny C, Bordier L, Rekik A, Zulfiqar AA, Bezerra CB, Bauduceau B. Evolution in geriatric syndromes and association with survival over 5 years in the GERODIAB cohort of older French diabetic patients. Eur Geriatr Med. 2021 Jun;12(3):619-625. doi: 10.1007/s41999-020-00425-9. Epub 2020 Nov 22.
- Derived from this study: PubMed 29859993Doucet J, Verny C, Balkau B, Scheen AJ, Bauduceau B. Haemoglobin A1c and 5-year all-cause mortality in French type 2 diabetic patients aged 70 years and older: The GERODIAB observational cohort. Diabetes Metab. 2018 Dec;44(6):465-472. doi: 10.1016/j.diabet.2018.05.003. Epub 2018 May 18.
- Derived from this study: PubMed 29113984Bauduceau B, Le Floch JP, Halimi S, Verny C, Doucet J; SFD/SFGG Intergroup. Cardiovascular Complications Over 5 Years and Their Association With Survival in the GERODIAB Cohort of Elderly French Patients With Type 2 Diabetes. Diabetes Care. 2018 Jan;41(1):156-162. doi: 10.2337/dc17-1437. Epub 2017 Nov 7.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by Association Pour la Recherche en Diabetologie et en Geriatrie.
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 6 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: status not confirmed, as of the sponsor's last update on 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Link between HbA1c level and the overall mortality rate at 5 years. (time frame: 5 years). 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 NCT01282060, which also lists 3 linked publications.
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 10 Jan 2017.