HypertensionNCT03422185
Understanding Local Determinants of Cardiovascular Disease and Diabetes
An observational study of Hypertension and Diabetes, run by Malawi Epidemiology and Intervention Research Unit at 1 site in Malawi.
Trial summary
Cross-sectional survey of all adults residing in two defined geographical regions in urban Lilongwe and rural Karonga District. Participants were interviewed, had anthropometric measures taken, and had fasting blood specimens taken. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Diabetes, Overweight and Obesity
- How many people
- 28,891 participants
- Where
- 1 siteMalawi
- Study dates
- May 2013to Feb 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All adults within 2 defined geographical areas - one in urban Lilongwe, one in rural Karonga District
Who may be able to join
- all adults over 18 self-identifying as normally resident in the pre-defined geographical areas
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Understanding Local Determinants of Cardiovascular Disease and Diabetes to Inform Novel Interventional Strategies
Cross-sectional survey of all adults residing in two defined geographical regions in urban Lilongwe and rural Karonga District. Participants were interviewed, had anthropometric measures taken, and had fasting blood specimens taken.
- Conditions
- Hypertension, Diabetes, Overweight and Obesity
- Being tested
- No intervention
- Medical subject headings
- Hypertension, Diabetes Mellitus, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
What is the true burden of hypertension, diabetes, and hyperlipidaemia?
Prevalence of hypertension (BP <140/90 or self-report of antihypertensive use), diabetes (fasting blood glucose >7.0 or self-report history of diabetes), and hyperlipidaemia
Measured: By end of 2018
Secondary outcomes (2)
What is the prevalence of known risk factors - notably smoking, obesity, physical inactivity, alcohol, salt, and saturated fat intake?
Description of prevalence of known risk factors of hypertension, diabetes, and hyperlipidaemia.
Dietary salt intake is estimated both by how long a defined quantity of salt is reported to last in a household on average, and from spot urine sodium specimens.
Measured: By end of 2020
Is infection, notably HIV infection or its therapy, associated with increased risk of NCDs?
Description of HIV infection and its therapy in relationship to hypertension, diabetes and hyperlipidaemia
Measured: By end of 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study startMay 2013
- Primary completionFeb 2015
- Study completionFeb 2015
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 HypertensionStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 28,891 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malawi Epidemiology and Intervention Research Unit
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422185
- Sponsor's protocol ID
- NCD
- Status last verified
- Apr 2018
- First submitted
- 30 Jan 2018
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Prynn JE, Banda L, Amberbir A, Price AJ, Kayuni N, Jaffar S, Crampin AC, Smeeth L, Nyirenda M. Dietary sodium intake in urban and rural Malawi, and directions for future interventions. Am J Clin Nutr. 2018 Sep 1;108(3):587-593. doi: 10.1093/ajcn/nqy125.
PubMed 29982267
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Local Determinants of Cardiovascular Disease and Diabetes to Inform Novel Interventional Strategies
- ClinicalTrials.gov ID
- NCT03422185
- Acronym / sponsor ID
- NCD
- Conditions
- Hypertension, Diabetes, Overweight and Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28,891 participants (actual)
- Lead sponsor
- Malawi Epidemiology and Intervention Research UnitUniversity, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 5 Feb 2018 (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.
Cross-sectional survey of all adults residing in two defined geographical regions in urban Lilongwe and rural Karonga District. Participants were interviewed, had anthropometric measures taken, and had fasting blood specimens taken.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All adults within 2 defined geographical areas - one in urban Lilongwe, one in rural Karonga District
Key inclusion criteria (1 listed)
- all adults over 18 self-identifying as normally resident in the pre-defined geographical areas
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
What is the true burden of hypertension, diabetes, and hyperlipidaemia?
Time frame: By end of 2018
Prevalence of hypertension (BP <140/90 or self-report of antihypertensive use), diabetes (fasting blood glucose >7.0 or self-report history of diabetes), and hyperlipidaemia
2 secondary outcomes
What is the prevalence of known risk factors - notably smoking, obesity, physical inactivity, alcohol, salt, and saturated fat intake?
Time frame: By end of 2020
Is infection, notably HIV infection or its therapy, associated with increased risk of NCDs?
Time frame: By end of 2020
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 17 Apr 2018.
- Derived from this study: PubMed 29982267Prynn JE, Banda L, Amberbir A, Price AJ, Kayuni N, Jaffar S, Crampin AC, Smeeth L, Nyirenda M. Dietary sodium intake in urban and rural Malawi, and directions for future interventions. Am J Clin Nutr. 2018 Sep 1;108(3):587-593. doi: 10.1093/ajcn/nqy125.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypertension and Diabetes, run by Malawi Epidemiology and Intervention Research Unit at 1 site in Malawi.
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 1 inclusion and 1 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 17 Apr 2018. 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 Malawi. 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?
What is the true burden of hypertension, diabetes, and hyperlipidaemia? (time frame: By end of 2018). 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 NCT03422185, 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 Apr 2018.