MAL-ED Metabolic: A Follow-Up of Chronic Disease at Puberty

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age9-17
SponsorUniversity of Virginia

About this trial

The concept that the roots of cardiometabolic disease start in early life was established by Dr. David Barker, who documented relationships between low birthweight (as a marker for challenges during gestation) and later cardiovascular disease (CVD). Later work has suggested that post-natal challenges (similar to prenatal ones) may also exhibit links to later cardiometabolic disease, with the strongest links appearing to be between low weight in early childhood and later hypertension and high waist circumference (WC). However, assessments for the relationship between early childhood challenges and insulin resistance and glucose regulation have been lacking and long-term cohort studies are few. In this project, we aim to assess children initially followed as part of The Etiology, Risk Factors, and Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health (MAL-ED) study, where they received frequent measures of anthropometry and laboratory assessments for intestinal pathogens. These children are now of peri-pubertal age--a time period associated with metabolic shifts. We will assess for glucose dysregulation and findings associated with the metabolic syndrome, and we will analyze potential associations between current chronic disease risk findings with early life poor growth and intestinal pathogen carriage rate. As such, we hope to uncover potential targets in early life health to reduce later chronic disease risk.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participated in original MAL-ED cohort

Disqualifiers

Did not participate in original MAL-ED cohort

Trial population

This is a follow-up study of children who were originally in the MAL-ED cohort.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

254 Participants
are grouped into 1 trial group
Group A: MAL-ED cohort

Trial outcomes

Primary outcomes

1

Current Systolic BP--relationship to number of enteric pathogens by age 2 years

Regression analysis of current systolic BP z-score vs. number enteric pathogens by age 2 years (from MAL-ED)

Time frame
Measured during current study (1 year +/- 3 months)

Secondary outcomes

1

Current Systolic BP--relationship to BMI z-score at age 2 years

Regression analysis of current systolic BP z-score vs. BMI z-score at age 2 years (from MAL-ED), adjusted for current BMI z-score

Time frame
Measured during current study (1 year +/- 3 months)
2

Current Diastolic BP--relationship to number of enteric pathogens by age 2 years

Regression analysis of current diastolic BP z-score vs. number enteric pathogens by age 2 years (from MAL-ED)

Time frame
Measured during current study (1 year +/- 3 months)
3

Current Diastolic BP--relationship to BMI z-score at age 2 years

Regression analysis of current diastolic BP z-score vs. BMI z-score at age 2 years (from MAL-ED), adjusted for current BMI z-score

Time frame
Measured during current study (1 year +/- 3 months)
4

Current BMI z-score--relationship to number of enteric pathogens by age 2 years

Regression analysis of current BMI z-score vs. number enteric pathogens by age 2 years (from MAL-ED)

Time frame
Measured during current study (1 year +/- 3 months)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Virginia

Lead sponsor

Haydom Lutheran Hospital

Collaborator

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