Identification of Infants at Risk for Type 1 Diabetes

Institut für Diabetesforschung, Helmholtz Zentrum München

Freder1k-Study - Testing Infants for Type 1 Diabetes Risk

Freder1k-Study - Identification of Infants With Increased Type 1 Diabetes Risk for Enrollment Into Primary Prevention Trials

increased risk will be identified by risk scores derived from SNPs

Anette-Gabriele Ziegler

Director - Institute of Diabetes Research

Helmholtz Zentrum München

A respresentative population of 275 Liberian children with SAM and admitted to a CMAM/IMAM program supported by Action Against Hunger (75 of which have a MUAC < 115, 75 of which have a WHZ < -3 and 75 of which have both a MUAC < 115 mm and a WHZ < -3).

A respresentative population of 275 Burkinabé children with SAM and admitted to a CMAM/IMAM program supported by Action Against Hunger (75 of which have a MUAC < 115, 75 of which have a WHZ < -3 and 75 of which have both a MUAC < 115 mm and a WHZ < -3).

A respresentative population of 275 Bangladeshi children with SAM and admitted to a CMAM/IMAM program supported by Action Against Hunger (75 of which have a MUAC < 115, 75 of which have a WHZ < -3 and 75 of which have both a MUAC < 115 mm and a WHZ < -3).

Severe Acute Malnutrition

Action Against Hunger, Bangladesh

Action Contre la Faim, Burkina Faso

Action Against Hunger, Liberia

Biomedical Investigations for Optimized Diagnosis and Monitoring of Severe Acute Malnutrition (SAM): Elucidating the Heterogeneous Diagnosis of SAM by Current Anthropometric Criteria and Moving Beyond

OptiDiag: Biomedical Investigations for Optimized Diagnosis and Monitoring of Severe Acute Malnutrition (SAM): Elucidating the Heterogeneous Diagnosis of SAM by Current Anthropometric Criteria and Moving Beyond

Describe and compare the different types of SAM anthropometric diagnoses based on circulating leptin.

Describe and compare the different types of SAM anthropometric diagnoses based on Stable Isotope Analysis (SIA)

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of clinical signs at admission; these include: dehydration, visible signs of wasting, pulse, signs of micronutrient deficiency, acute resipiratory infections, respiratory rate, temperature, dermatosis and hair changes and diarrhea.

Describe and compare the different types of SAM anthropometric diagnoses based on micronutrient status.

Describe and compare the different types of SAM anthropometric diagnoses based on bioelectric impedance (BI).

Describe and compare the different types of SAM anthropometric diagnoses based on the caretaker's perception of the patient's health and nutritional status.

Describe and compare the different types of SAM anthropometric diagnoses based on the history of lipid and protein catabolism (δ13C and δ15N isotopes in hair) reversed throughout nutritional rehabilitation.

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of clinical signs for dehydration at admission and the development of clinical signs of dehydration during treatment.

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of clinical signs of visible wasting at admission and the development of clinical signs of visible wasting during treatment.

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of abnormal pulse at admission and the development of abnormal pulse during treatment.

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of clinical signs of micronutrient deficency at admission and the development of clinical signs of micronutrient deficency during treatment.

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of clinical signs of acute respiratory infection at admission and the development of clinical signs of acute respiratory infection during treatment.

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of abnormal respiratory rate at admission and the development of clinical signs of abnormal respiratory rate during treatment.

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of abnormal temperature at admission and the development of clinical signs of abnormal temperature during treatment.

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of clinical signs of dermatosis at admission and the development of clinical signs of dermatosis during treatment.

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of clinical signs of hair change (color and consistency) linked to acute malnutrition at admission and the development of clinical signs of of hair change (color and consistency) during treatment.

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of diarrhea at admission and the development of diarrhea during treatment.

Describe and compare the different types of SAM anthropometric diagnoses based on negative and positive treatment outcomes; these include: discharged from program as recovered [mid-upper arm circumference (MUAC) ≥ 125 and weight-for-height Z-score (WHZ) ≥ -2], defaulted from program (caretaker confirmation of unwillingness to participate), death, transfer to an in-patient facility (developement of medical complications as per national protocol, loss of or static weight), transfer to another out-patient facility outside of the program catchment area and facility and non-response to treatment (cure criteria unattained before maximum treatment duration).

Describe and compare the different types of SAM anthropometric diagnoses based on early weight gain.

Describe and compare the different types of SAM anthropometric diagnoses based on circulating leptin

Describe and compare the different types of SAM anthropometric diagnoses based on bioelectric impedance.

Measures of household wealth reflected by durable assets, source of water supply, sanitation favility, type of floor material, type of cooking fuel, transportation, livestock, homestead or land area, bank account, number of family members per sleeping room.

The HFIAS is composed of a set of nine questions that have been used in several countries and appear to distinguish food insecure from food secure households across different cultural contexts.

Individual dietary diversity scores (IDDS) validated for age/sex groups.

Action Contre la Faim

Duke University

University Ghent

AgroParisTech

University College, London

Humanitarian Innovation Fund

European Commission's Directorate-General for European Civil Protection and Humanitarian Aid Operations

Empagliflozin (Jardiance™) 25mg once daily (orally)

Empagliflozin (Jardiance™) 25mg once daily (orally) + energy restriction diet

Placebo once daily (orally) + energy restriction diet

Diabetes Mellitus, Type 2

25mg once daily to be taken orally for the duration of the study (24 weeks)

Empagliflozin

Daily energy restriction diet to be followed for the duration of the study (24 weeks)

Diet

Placebo once daily for the duration of the study (24 weeks)

Placebo

Leicester Diabetes Centre

SGLT-2 Inhibitor Empagliflozin Effects on Appetite and Weight Regulation.

SGLT-2 Inhibitor Empagliflozin Effects on Appetite and Weight Regulation: A Randomised Double-blind Placebo-controlled Trial (The SEESAW Study)

The effect of Empagliflozin on appetite hormone 'Total PYY' concentration between baseline and 24 weeks. Measured by sequential blood sampling at study visits 1-5.

Change in appetite hormone 'Ghrelin' concentration from baseline to 24 weeks. Measured by blood sampling at study visits 1-5.

Change in appetite hormone 'GLP-1' concentration from baseline to 24 weeks. Measured by blood sampling at study visits 1-5.

Change in appetite perceptions from baseline to 24 weeks. Measured by questionnaires visits 1 -5.

Change in weight (kg) from baseline to study end and between groups. This will be measured at visits 1 - 5.

Change in body composition from baseline to study end and between groups. This will be measured by Dual Energy X-Ray Absorptiometry (DEXA) scanning at visits 1 and 5.

Change in resting energy expenditure from baseline to study end and between groups. This will be measured by indirect calorimetry at visits 1-5.

Change in physical activity from baseline to study end and between groups. This will be measured using physical activity monitors at visits 0, 3, 4 and 5.

Change in physical activity from baseline to study end and between groups. This will be measured using the international physical activity questionnaire at visits 1 - 5.

Change in urine glucose excretion to study end and between groups. This will be measured using urine sampling at visits 1-5.

Change in in baseline blood appetite hormones to 24 weeks between groups. This will be measured using blood sampling at visits 1-5.

Change in in baseline HbA1c to 24 weeks between groups. This will be measured using blood sampling at visits 1-5.

Change in in baseline inflammatory markers to 24 weeks between groups. This will be measured using blood sampling at visits 1-5.

Change in in baseline renal functioning to 24 weeks between groups. This will be measured using blood sampling at visits 1-5.

Change in in baseline liver functioning to 24 weeks between groups. This will be measured using blood sampling at visits 1-5.

University of Leicester

Loughborough University

University Hospitals, Leicester

Circadian Dysregulation

Ramelteon 1 mg, tablets, orally, once nightly for 4 nights.

Ramelteon

Ramelteon 4 mg, tablets, orally, once nightly for 4 nights.

Ramelteon 8 mg, tablets, orally, once nightly for 4 nights.

Ramelteon placebo-matching tablets, orally, once nightly for 4 nights.

Efficacy of Ramelteon on Insomnia Symptoms Associated With Jet Lag in Healthy Adult Volunteers

A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Ability of Ramelteon 1 mg, 4 mg, and 8 mg to Alleviate the Insomnia Symptoms Associated With Eastward Bound Jet Lag Across 5 Time Zones in Healthy Adult Volunteers

ketosis/fatigue

Freder1k-Study - Testing Infants for Type 1 Diabetes Risk

Biomedical Investigations for Optimized Diagnosis and Monitoring of Severe Acute Malnutrition (SAM): Elucidating the Heterogeneous Diagnosis of SAM by Current Anthropometric Criteria and Moving Beyond

SGLT-2 Inhibitor Empagliflozin Effects on Appetite and Weight Regulation.

Efficacy of Ramelteon on Insomnia Symptoms Associated With Jet Lag in Healthy Adult Volunteers

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