240 black boys were included in the study (mean age 7.5 years)

339 black girls were included in the study (mean age 7.5 years)

239 white boys were included in the study (mean age 7.4 years)

224 white girls were included in the study (mean age 7.4 years)

Biological samples for biomarker analyses (spot urine and saliva) were taken at baseline and also for each follow-up. Samples are preserved for both short and long-term at -80°C. We aim to assess a variety of traditional and new biomarkers related to hypertension and cardiovascular disease. Saliva samples - not for DNA purposes Urine samples - only for non-coding mRNA analysis

Hypertension

Retinal Artery Stenosis

Childhood Obesity

Hypertension in Africa Research Team (HART), North-West University

The Exercise, Arterial Modulation and Nutrition in Youth South Africa Study

The Exercise, Arterial Modulation and Nutrition in Youth South Africa (ExAMIN Youth SA) Study

Elevated blood pressure and stage 1 hypertension according to the American Academy of Pediatrics Clinical Practice Guidelines 2017 stratified for age, sex, weight and height. Automated oscillometric calculations of central systolic blood pressure and pulse wave velocity.

Overweight and obesity classification according to the World Health Organisation percentiles for childhood obesity

Multiplex analysis of cardiovascular and kidney related biomarkers, and subsequently metabolomics and hormone concentrations

Physical fitness (cardiorespiratory fitness, coordination, endurance, speed, balance) and activity (accelerometry)

Anthropometry including body heigh, body weight, waist-to-height ratio, and body fat percentage

Healthy and unhealthy food consumption frequencies determined by validate survey to depict unhealthy and healthy food group patterns

Early life stress events as quantified by validated psychosocial questionnaires.

Automated oscillometric calculations of central systolic blood pressure and pulse wave velocity at baseline and 4-years follow-up

Target organ damage will be assessed at follow-up by carotid intima media thickness and left ventricular mass.

Ruan Kruger

Associate Professor

North-West University, South Africa

National Research Foundation of South Africa

Medical Research Council, South Africa

TBI with initial Glasgow Coma Scale (GCS) ≤ 8 and AISextrahead score ≤3. Oropharyngeal and rectal swabs will be performed for each patient within the first 24 hours after ICU admission (day 0), then 48 hours (day 2) and 7 days (day 7) after ICU admission and weekly thereafter until ICU discharge.

Patients with severe trauma without TBI (AISextrahead score > 3). Oropharyngeal and rectal swabs will be performed for each patient within the first 24 hours after ICU admission (day 0), then 48 hours (day 2) and 7 days (day 7) after ICU admission and weekly thereafter until ICU discharge.

Persons who have not had the conditions being studied or otherwise related conditions or symptoms, as specified in the eligibility requirements.
Oropharyngeal and rectal swabs will be taken only once, at inclusion, after that the participation of the control individual in the trial will be completed.

Biospecimen types : - Oropharyngeal swabs - Rectal swabs The swabs will be performed for each patient within the first 24 hours after ICU admission (day 0), then 48 hours (day 2) and 7 days (day 7) after ICU admission and weekly thereafter until ICU discharge. Rectal and oropharyngeal swabs will be performed by trained paramedical staff using sterile swabs with transport medium ESwab® (Becton, Dickinson and Company, New Jersey, USA). Swabs will be stored at -80°C until bacterial DNA extraction.

Traumatic Brain Injury

Multiple Trauma

Will be performed by trained paramedical staff using sterile swabs with transport medium ESwab® (Becton, Dickinson and Company, New Jersey, USA). Swabs will be stored at -80°C until DNA extraction.

Oropharyngeal swab

Rectal swab

Disability rating scale (DRS-F)

APHP Bicêtre Hospital

Evolution of Oropharyngeal and Rectal Microbiota After Severe Traumatic Brain Injury

From the Brain to the Bugs: Evolution of Oropharyngeal and Rectal Microbiota of Patients With Severe Traumatic Brain Injury Admitted in ICU

The oropharyngeal and rectal swabs, performed at day 0, day 2, day 7 after ICU admission and weekly thereafter until ICU discharge or no later than day 90, will be used for DNA extraction and the bacterial 16S rRNA amplification and sequencing in order to identify the bacterial species colonizing the gut.

The oropharyngeal and rectal swabs, performed at day 0, day 2, day 7 after ICU admission and weekly thereafter until ICU discharge or no later than day 90, will be used for DNA extraction and the bacterial 16S rRNA amplification and sequencing in order to identify the bacterial species.

The ICU-acquired infection rates during the ICU stay

Multidrug resistant bacteria colonisation or infection acquired during the ICU stay

The rates of deaths at ICU discharge and 90 days post trauma

Neurological outcome at 90 days post trauma evaluated by the Disability Rating Scale, the French translation (DRS-F) quoted from 0 (no disability) to 29 (extreme vegetative state)

Assistance Publique - Hôpitaux de Paris

Paris-Saclay University

One arm study in Overweight Type 2 Diabetes Mellitus

Overweight Type 2 Diabetes Mellitus

Sex: Female, Male

Region of Enrollment

Change: Weight after 12 months of therapy or more - weight at baseline

Change in Weight From Baseline at 12 Months or More

Change: Body Mass Index (BMI) after 12 months of therapy or more - BMI at baseline

Change in Body Mass Index (BMI) From Baseline at 12 Months or More

Change: Waist circumference after 12 months or more of therapy - Waist circumference at baseline

Change in Waist Circumference From Baseline at 12 Months or More

Change: Waist circumference/Hip circumference ratio after 12 months or more of therapy - Waist circumference/Hip circumference ratio at baseline

Change in Waist Circumference (Cms)/Hip Circumference (Cms)From Baseline at 12 Months or More

Change: Waist/Height ratio after 12 months or more of therapy - Waist/Height ratio at baseline

Change in Waist (Cms) /Height (Meters) Ratio From Baseline at 12 Months or More

Change: Fasting blood glucose after 12 months or more of therapy - Fasting blood glucose at baseline

Change in Fasting Blood Glucose From Baseline at 12 Months or More

Change: Glycosylated Haemoglobin after 12 months or more of therapy - Glycosylated Haemoglobin at baseline.

Change in Glycosylated Haemoglobin (A1C) From Baseline at 12 Months or More

Metformin in Maximum Tolerated Dose

Metformin for 12 Months or More

Dr. Amulya R Sircar

Obesity

Type 2 Diabetes Mellitus

0.5g twice a day to 2g twice a day for at least 12 months or more

Extended Release Metformin

Sircar Diabetes Clinic

Metformin in Overweight Type 2 Diabetes Mellitus

Metformin Monotherapy Significantly Improves Anthropometric and Glycemic Values in Overweight Type 2 Diabetes Mellitus: One Year or More Prospective Study.

mydriasis/obezita

The Exercise, Arterial Modulation and Nutrition in Youth South Africa Study

Evolution of Oropharyngeal and Rectal Microbiota After Severe Traumatic Brain Injury

Metformin in Overweight Type 2 Diabetes Mellitus

Mannheim Obesity Study

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