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CompletedNCT03422185Updated Apr 17, 2018

Understanding Local Determinants of Cardiovascular Disease and Diabetes

An observational study in Hypertension, Diabetes and Overweight and Obesity, sponsored by Malawi Epidemiology and Intervention Research Unit. Completed at 1 site in Malawi. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-17.

Sponsored by Malawi Epidemiology and Intervention Research Unit · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
28,891
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hypertension
  • Diabetes
  • Overweight and Obesity
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

All adults within 2 defined geographical areas - one in urban Lilongwe, one in rural Karonga District

Inclusion criteria

  • all adults over 18 self-identifying as normally resident in the pre-defined geographical areas

Exclusion criteria

Exclusion Criteria:

  • None
04

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
28,891 participants (actual)
Patient registry
No

Interventions

  • OtherNo intervention

    No intervention

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: By end of 2018

Secondary outcomes

  1. 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.

    Time frame: By end of 2020

  2. 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

    Time frame: By end of 2020

06

Study locations

1 site
  • MEIRU
    Lilongwe, Malawi
07

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03422185
Lead sponsor
Malawi Epidemiology and Intervention Research Unit
Responsible party
Sponsor
First posted
Feb 5, 2018
Start date
May 2013
Primary completion
Feb 2015
Completion
Feb 2015
Last update
Apr 17, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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