Diabete MellitusNCT07048717
The Mauritius and Rodrigues Non-Communicable Disease (NCD) Study
An observational study of Diabete Mellitus and Cardiovascular Disease Risk Factor, run by Umeå University at 1 site in Mauritius.
Trial summary
Mauritius is located in the southern Indian Ocean with a population of 1.3 million in 2023. Mauritius is a multiethnic nation with 68% South Asian, 27% African (Creole), 3% Chinese and 2% Franco Mauritians. Read more about this study
- Who is it for?
- Ages 25 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabete Mellitus, Cardiovascular Disease Risk Factor, Ischemic Cardiovascular Disease
- How many people
- 39,082 participants
- Where
- 1 siteMauritius
- Study dates
- 5 Apr 1987to 31 Dec 2050
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 25 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Random samples from the Mauritian (including Rodrigues) aged 25 to 74 years
Who may be able to join
- Men and women
- Randomly selected population-based samples (details see below)
- Target age from 25 to 74 years Exclusion
- Not living in the study area
- Age outside the age-range
- In detail:
Show all 11Show fewer
- Inclusion Criteria In 1987, 10 randomly selected (with probability proportional to size) population clusters and a purposely selected area of Chinatown in the capital, Port Louis, were surveyed (age range 25-74), and all eligible residents were invited to participate.2 In 1992 and 1998, the same clusters were resurveyed as well as an additional three clusters selected to assess if trends in disease and risk factor distribution observed in the study cohort also occurred in independent clusters (age range 25 years and older). In 1998, the Chinatown cluster was not surveyed. Altogether, 9,559 individuals participated in the first three surveys and 60% of participants took part in more than one survey.
- In 2004, a new study was performed, with similar methodology. In 2009, nine index clusters were chosen with one randomly selected from each of the nine districts in Mauritius. Then, two neighbouring clusters were chosen surrounding the index cluster to form a "super cluster." From this super cluster, one in three households was randomly selected and one adult per household was invited to participate.5 The same methodology was used in 2015 and in 2021 with new randomly chosen clusters forming "super cluster" as in 2009. In addition, a random sample from the 1998 survey was invited for a resurvey in 2015.
- Participation rate has been over 85% in each survey. No sampling weights were used.
- Same methodology was used in Rodrigues.
- Exclusion Criteria Outside age-range and not being randomly selected.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Mauritius is located in the southern Indian Ocean with a population of 1.3 million in 2023. Mauritius is a multiethnic nation with 68% South Asian, 27% African (Creole), 3% Chinese and 2% Franco Mauritians.
Seven population-based cross-sectional surveys using standardised protocols were conducted between 1987 and 2021). The participation rate has been over 85% in each survey.
Read more
At each survey, participants were interviewed about living conditions, lifestyle and health, and anthropometry and blood pressure were measured. Biochemistry including lipids and an oral glucose tolerance test (OGTT) were performed Electrocardiograms (ECG) were recorded in participants aged 35 years and older. Previous participants were followed up in 2007 and 92% were successfully traced.
Studies with identical methodology have been performed on the neighbouring island Rodrigues where the majority of the population are Creoles.
Read the detailed description
Mauritius and Rodrigues are islands in the south-eastern part of the Indian Ocean. Major changes in lifestyle have been seen during the last fifty years, including less physical activity and introduction of a westernised diet. In parallel, the disease panorama has changed from high infant mortality and infectious diseases to lifestyle-related diseases such as cardiovascular disease and type 2 diabetes.
The population in Mauritius are descendants to immigrants from South Asia, Africa and China, i.e., approximately 60% of the world population are represented. Mauritius is probably the only developing country that has followed the development of non-communicable diseases (NCD) and associated risk factors over a long time-period and continues to do so.
In the mid-eighties, the Mauritian government initiated a study on the prevalence of type 2 diabetes and cardiovascular disease, in collaboration with WHO and international experts. Altogether seven population-based surveys have been performed between 1987 and 2021, and approximately 39 000 (!) examinations have been recorded. The intention is to repeat the survey every fifth year.
The ethnicities of the participants have been 71% South Asians (India/Pakistan), 24% Creoles (Africa) and 5% Chinese, which reflects well the ethnical distribution of the population. Previous participants were followed up in 2007 and 92% were successfully traced. Studies have also been performed on the neighbouring island Rodrigues where the majority of the population are Creoles. During the follow-up survey in 2010, 97% of the 9 700 participants were traced.
At each survey, information was given and an individual consent form was signed. See attached the local (in Mauritius) ethical approval and consent form from the Mauritius survey 2021.
At each survey, participants were interviewed about living conditions, lifestyle and health, and anthropometry and blood pressure were measured. Biochemistry including lipids and an oral glucose tolerance test (OGTT) were performed Altogether approximately 28 000 electrocardiograms (ECG) were recorded in participants aged 35 years and older, all of which have been coded in Kaunas, Lithuania for signs of ischemic heart disease (Minnesota criteria) and myocardial hypertrophy.
The Mauritius NCD study was initially administrated by the International Diabetes Institute in Melbourne, Australia under the leadership of Professor Paul Zimmet together with Professor Jaakko Tuomilehto (Finland) and Professor George Alberti (United Kingdom). Today, the study is administrated and financed by the Ministry of health in Mauritius under the leadership of Doctor Sudhir Kowlessur.
Professor Stefan Söderberg at the Department of Public Health and Clinical Medicine, Umeå University, Sweden was introduced to the Mauritius NCD study during his postdoc (2001-2002) in Professor Zimmet's research team at IDI in Melbourne. Söderberg has since then continued to assist in the performance of the surveys and to analyse data. Today, Umeå university and the Department of Public Health and Clinical medicine have been granted the privilege to curate and analyse data generated in the Mauritius and Rodrigues NCD study.
Each survey has been evaluated and approved by the local ethics committee in Mauritius (see attached the approval from 2021). Analysing data in Sweden has been approved by the Swedish Ethical Authority (2023-07199-01).
- Conditions
- Diabete Mellitus, Cardiovascular Disease Risk Factor, Ischemic Cardiovascular Disease, Hypertension, Obesity &Amp; Overweight
- Keywords
- Epidemiology, Cross-sectional studies, Prevalence, Incidence, Diabetes mellitus, Cardiovascular Disease
- Medical subject headings
- Diabetes Mellitus, Hypertension, Obesity, Overweight, Cardiovascular Diseases
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 |
|---|---|---|
| Randomly selected population-based subjects from the population (Mauritius) | Seven cross-sectional studies were performed between 1987 and 2021 on mainland Mauritius | |
| Randomly selected population-based subjects from the population (Rodrigues) | In parallell, six cross-sectional studies were performed between 1992 and 2022 on Rodrigues |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
According to household interviews, death certificates from central registers at Ministry of Health and Wellness.
- Household interviews: "Is the participant alive? If dead, do you have a copy of the death certificate? When did the participant die?"
- Central registers: Vital status, if dead, date and cause of death from death certificates"
Combining 1 and 2 will give date and cause of death.
Absolute numbers and mortality rates will be reported for all and in subgroups i.e. sex, age-strata, ethnicity.
Measured: Up to 20 years from the baseline survey
Secondary outcomes (4)
Diabetes Mellitus
Determined according to WHO criteria. i.e. data from oral glucose tolerance tests and questionnaires (glucose-lowering medication).
- A 75-g oral glucose-tolerance test is used on all non-pregnant participants, except those taking insulin or oral hypoglycaemic drugs, was performed after an overnight fast, and plasma glucose (mmol/L) are measured before the test and after two hours.
- The questionnaire includes the question: "Do you take glucose-lowering medication, insulin or tablets, yes/no".
The participant has diabetes if fasting glucose ≥ 7.0 mmol/ and/or two-hour glucose ≥ 11.1 mmol/L and/or answer yes to taking glucose lowering medication, and prediabetes if fasting glucose ≥ 6.1 and < 7.0 mmol/L and/or two-hour glucose ≥ 7.8 and < 11.1 mmol/L.
Numbers and age-standardised incidence and prevalence of prediabetes and diabetes will be reported for all and in subgroups.
Measured: Up to 20 years from the baseline survey
Cardiovascular disease (CVD)
Determined by analysis of serial ECG recordings, data from official registers and questionnaires.
ECGs and signs of coronary heart disease (CHD) according to the Minnesota Code (MC) classification. Probable CHD (MC: 1-1 to 1-2 (large Q and QS)) and possible (CHD) (MC: 1-3 (small Q and QS), 4-1 to 4-4 (ST depression), 5-1 to 5-3 (T wave inversion and flat) and 7-1 (left bundle branch block)). Probable CHD will be interpreted as previous myocardial infarction (MI).
From central registers: Date and related ICD 10 codes for hospital admissions. ICD codes I21-23 will be interpreted as MI, and I60-61 and I63-64 as stroke.
Survey: Affirmative answer to any of these questions: Do you have angina, myocardial infarction (including by-pass surgery and PCI), and/or stroke" will be labelled as previous CVD.
CVD is present if probable CHD and/or ICD codes found for MI or stroke and/or affirmative answer to surve questions.
Measured: Up to 20 years from the baseline survey
Hypertension
Blood pressure (BP) is measured using an automated BP monitor (Omron Digital Auto Blood Pressure Monitor).
The questionnaire includes the question: "Do you take BP lowering medication, yes/no".
Hypertension is defined as a systolic BP ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg, and/or answer "yes" to the use of BP lowering drugs.
Numbers and age-standardised incidence and prevalence of hypertension will be reported for all and in subgroups.
Measured: Up to 20 years from the baseline survey
Obesity
Height (in meter, m) and weight (in kilogram, kg) will be measured in light clothing without shoes.
Waist circumference (in centimeter, cm) is measured as the circumference at the mid-point between the iliac crest and the lower margin of the ribs. Hip circumference (in centimeter, cm) is taken as the horizontal measure around the pelvis at the point of maximal protrusion of the buttocks.
Waist and hip circumference are measured twice, and the mean will be calculated.
Body mass index (BMI) is calculated as weight divided by height squared (kg/m2), and waist to hip ratio (WHR) as waist circumference (cm) divided by hip circumference (cm).
Obesity is defined according to BMI as ≥ 30 kg/m2, and central obesity according to waist circumference using ethnic-specific cut-offs.
Numbers and age-standardised incidence and prevalence of obesity and central obesity will be reported for all and in subgroups.
Measured: Up to 20 years from the baseline survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start5 Apr 1987
- Primary completion23 Nov 2021
- Study completion31 Dec 2050 (estimated)
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 Diabete MellitusStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 39,082 participants (actual)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Wellness, Mauritius, University of Helsinki, Monash University, Imperial College London, Baker Heart and Diabetes Institute
- Responsible party
- Principal investigator, Stefan Soderberg, Umeå University
- Investigators
- Paul Zimmet, Professor, Principal investigator, Monash UniversityGeorge Alberti, Professor, Principal investigator, Imperial College, London, UKJaakko Tuomilehto, Professor, Principal investigator, Helsinki University, Helsinki, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048717
- Sponsor's protocol ID
- 2023-07199-01
- Other IDs
- 2023
- Status last verified
- Jul 2025
- First submitted
- 24 Jun 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If you would like to use the data from the Mauritius study, you should contact the Section of Biobank and Registry Support (BRS) at Umeå University, Sweden for discussion: info.brs@umu.se. Before sharing of data, the application will be evaluated by senior researchers within the network. Ethical approval must be obtained.
Publications
Soderberg S, Taki H, Kowlessur S, Shaw JE, Magliano DJ, Tamosiunas A, Alberti G, Zimmet P, Tuomilehto J. Trends in the prevalence of cardiovascular disease, defined as ECG abnormalities and/or self-reported events, in Mauritius between 1987 and 2021: analysis of data from seven large population-based surveys. BMJ Open. 2025 Jun 16;15(6):e087693. doi: 10.1136/bmjopen-2024-087693.
PubMed 40523792
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mauritius and Rodrigues Non-Communicable Disease (NCD) Study
- ClinicalTrials.gov ID
- NCT07048717
- Acronym / sponsor ID
- 2023-07199-01
- Conditions
- Diabete Mellitus, Cardiovascular Disease Risk Factor, Ischemic Cardiovascular Disease, Hypertension, Obesity &Amp; Overweight
- Keywords
- Epidemiology, Cross-sectional studies, Prevalence, Incidence, Diabetes mellitus, Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 39,082 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health and Wellness, Mauritius, University of Helsinki, Monash University, Imperial College London, Baker Heart and Diabetes Institute
- Study start
- 5 Apr 1987 (actual)
- Primary completion
- 23 Nov 2021 (actual)
- Study completion
- 31 Dec 2050 (estimated)
- First posted
- 2 Jul 2025 (actual)
- 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.
Mauritius is located in the southern Indian Ocean with a population of 1.3 million in 2023. Mauritius is a multiethnic nation with 68% South Asian, 27% African (Creole), 3% Chinese and 2% Franco Mauritians.
Seven population-based cross-sectional surveys using standardised protocols were conducted between 1987 and 2021). The participation rate has been over 85% in each survey.
At each survey, participants were interviewed about living conditions, lifestyle and health, and anthropometry and blood pressure were measured. Biochemistry including lipids and an oral glucose tolerance test (OGTT) were performed Electrocardiograms (ECG) were recorded in participants aged 35 years and older. Previous participants were followed up in 2007 and 92% were successfully traced.
Studies with identical methodology have been performed on the neighbouring island Rodrigues where the majority of the population are Creoles.
Detailed description
Mauritius and Rodrigues are islands in the south-eastern part of the Indian Ocean. Major changes in lifestyle have been seen during the last fifty years, including less physical activity and introduction of a westernised diet. In parallel, the disease panorama has changed from high infant mortality and infectious diseases to lifestyle-related diseases such as cardiovascular disease and type 2 diabetes.
The population in Mauritius are descendants to immigrants from South Asia, Africa and China, i.e., approximately 60% of the world population are represented. Mauritius is probably the only developing country that has followed the development of non-communicable diseases (NCD) and associated risk factors over a long time-period and continues to do so.
In the mid-eighties, the Mauritian government initiated a study on the prevalence of type 2 diabetes and cardiovascular disease, in collaboration with WHO and international experts. Altogether seven population-based surveys have been performed between 1987 and 2021, and approximately 39 000 (!) examinations have been recorded. The intention is to repeat the survey every fifth year.
The ethnicities of the participants have been 71% South Asians (India/Pakistan), 24% Creoles (Africa) and 5% Chinese, which reflects well the ethnical distribution of the population. Previous participants were followed up in 2007 and 92% were successfully traced. Studies have also been performed on the neighbouring island Rodrigues where the majority of the population are Creoles. During the follow-up survey in 2010, 97% of the 9 700 participants were traced.
At each survey, information was given and an individual consent form was signed. See attached the local (in Mauritius) ethical approval and consent form from the Mauritius survey 2021.
At each survey, participants were interviewed about living conditions, lifestyle and health, and anthropometry and blood pressure were measured. Biochemistry including lipids and an oral glucose tolerance test (OGTT) were performed Altogether approximately 28 000 electrocardiograms (ECG) were recorded in participants aged 35 years and older, all of which have been coded in Kaunas, Lithuania for signs of ischemic heart disease (Minnesota criteria) and myocardial hypertrophy.
The Mauritius NCD study was initially administrated by the International Diabetes Institute in Melbourne, Australia under the leadership of Professor Paul Zimmet together with Professor Jaakko Tuomilehto (Finland) and Professor George Alberti (United Kingdom). Today, the study is administrated and financed by the Ministry of health in Mauritius under the leadership of Doctor Sudhir Kowlessur.
Professor Stefan Söderberg at the Department of Public Health and Clinical Medicine, Umeå University, Sweden was introduced to the Mauritius NCD study during his postdoc (2001-2002) in Professor Zimmet's research team at IDI in Melbourne. Söderberg has since then continued to assist in the performance of the surveys and to analyse data. Today, Umeå university and the Department of Public Health and Clinical medicine have been granted the privilege to curate and analyse data generated in the Mauritius and Rodrigues NCD study.
Each survey has been evaluated and approved by the local ethics committee in Mauritius (see attached the approval from 2021). Analysing data in Sweden has been approved by the Swedish Ethical Authority (2023-07199-01).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 20 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Randomly selected population-based subjects from the population (Mauritius) | – | –Seven cross-sectional studies were performed between 1987 and 2021 on mainland Mauritius |
| Randomly selected population-based subjects from the population (Rodrigues) | – | –In parallell, six cross-sectional studies were performed between 1992 and 2022 on Rodrigues |
Who may qualify
- Ages
- 25 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Random samples from the Mauritian (including Rodrigues) aged 25 to 74 years
Key inclusion criteria (11 listed)
- Men and women
- Randomly selected population-based samples (details see below)
- Target age from 25 to 74 years Exclusion
- Not living in the study area
- Age outside the age-range
Key exclusion criteria (0 listed)
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
Mortality
Time frame: Up to 20 years from the baseline survey
According to household interviews, death certificates from central registers at Ministry of Health and Wellness. 1. Household interviews: "Is the participant alive? If dead, do you have a copy of the death certificate? When did the participant die?" 2. Central registers: Vital status, if dead, date and cause of death from death certificates" Combining 1 and 2 will give date and cause of death. Absolute numbers and mortality rates will be reported for all and in subgroups i.e. sex, age-strata, ethnicity.
4 secondary outcomes
Diabetes Mellitus
Time frame: Up to 20 years from the baseline survey
Cardiovascular disease (CVD)
Time frame: Up to 20 years from the baseline survey
Hypertension
Time frame: Up to 20 years from the baseline survey
Obesity
Time frame: Up to 20 years from the baseline survey
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Results publication: PubMed 40523792Soderberg S, Taki H, Kowlessur S, Shaw JE, Magliano DJ, Tamosiunas A, Alberti G, Zimmet P, Tuomilehto J. Trends in the prevalence of cardiovascular disease, defined as ECG abnormalities and/or self-reported events, in Mauritius between 1987 and 2021: analysis of data from seven large population-based surveys. BMJ Open. 2025 Jun 16;15(6):e087693. doi: 10.1136/bmjopen-2024-087693.
- Description of the Mauritian/Rodrigues NCD survey at Umeå University, SwedenLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. If you would like to use the data from the Mauritius study, you should contact the Section of Biobank and Registry Support (BRS) at Umeå University, Sweden for discussion: info.brs@umu.se. Before sharing of data, the application will be evaluated by senior researchers within the network. Ethical approval must be obtained.
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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.
Paul Zimmet, Professor principal investigator
Monash University
George Alberti, Professor principal investigator
Imperial College, London, UK
Jaakko Tuomilehto, Professor principal investigator
Helsinki University, Helsinki, Finland
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 Diabete Mellitus and Cardiovascular Disease Risk Factor, run by Umeå University at 1 site in Mauritius.
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 11 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2025. 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 Mauritius. 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?
This study is still under way. Results are not available in the source record yet.
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?
Mortality (time frame: Up to 20 years from the baseline survey). 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 NCT07048717, 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 17 Jul 2025.