Criticality Analysis of Diabetic Gait Within a Primary Care Pediatric Clinic for Obese Children (PAIDOS)

Study Overview
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Brief Summary
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One of the difficulties with diabetes care is the problem of predicting progression to more severe stages using current measures (for example blood glucose, HbA1c). This feasibility study aims to use Criticality Analysis (CA) of gait to monitor the progression of the condition as well as identifying individuals at risk of developing diabetes among children in Mexico.The study will investigate whether gait analysis can be used as a fast, reliable and cost effective way to detect individuals at risk of developing Type 2 Diabetes (T2DM) as early treatment could reduce the number of cases that develop into full T2DM.

Detailed Description
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This feasibility study aims to the do the following: To evaluate the use of Criticality Analysis of Gait as means of Diabetes assessment. To design and set up a clinical feasibility study in a hospital (Hospital Infantil de Mexico) with adolescent patients on different clinical stages of type 2 Diabetes mellitus (DM). To analyse the collected data and validate Gait data analysis as mechanism for identifying and monitoring pre-diabetic teenagers. To use the feasibility study conducted in Mexico to develop a robust method using Gait analysis for diabetes prevention and management. Participants will be selected from the Primary Care Pediatric Clinic for Obese Children (PAIDOS) in the Hospital Infantil de México Federico Gómez, Mexico City, Mexico. Sixty participants will be selected and divided into three groups: 40 obese non-diabetic subjects, 10 with Type 2 Diabetes and 10 healthy subjects as controls. Obese participants within the Paidos clinic will undergo standard clinical care that includes dietary prescription of caloric intake according to height, 150 min weekly physical activity, group cognitive-behavioural intervention, 6 session of obesity awareness and educational program. Gait will be recorded in all groups using a sensor on the 4th vertebrae of the lumbar spine, once a week across 6 weeks during the routine PAIDOS clinic. Critical changes in walking control, stride frequency and length will be observed as individuals change speed; effectively stressing their mobility. The study will be repeated after 3-6 months as a follow up. Data analysis will be performed in a semi-blind manner in order to test the efficacy of the criticality analysis Rate control of Chaos (RCC) model. In order to provide an objective measure of analysis, the anonymised data will be presented to the nonlinear RCC models, where results can be extracted and compared afterwards to known states.

Official Title
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Criticality Analysis of Diabetic Gait Within the PAIDOS Pediatric Clinic for Obese Children (PAIDOS: Pediatric Attention Integral and Dynamic for Obese Children Program)- A Feasibility Study

Conditions
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Childhood Obesity

Intervention / Treatment
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* Diagnostic Test: Gait analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI over 95 th percentile for age Living in Major Mexico City area Exclusion Criteria: Diabetic patients major physical disability

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obese teenagers within the PAIDOS clinic<br>Obese children within the PAIDOS clinic, Hospital Infantil de Mexico Federico Gomez, Mexico City, Mexico. | Diagnostic Test: Gait analysis<br>* Gait recorded using a sensor on the 4th vertebrae of the lumbar spine, once a week across 6 weeks during the routine PAIDOS clinic. Critical changes in walking control, stride frequency and length will be observed as individuals change speed; effectively stressing their mobility.<br>|
| Healthy children<br>Healthy children living in Mexico City, Mexico. | Diagnostic Test: Gait analysis<br>* Gait recorded using a sensor on the 4th vertebrae of the lumbar spine, once a week across 6 weeks during the routine PAIDOS clinic. Critical changes in walking control, stride frequency and length will be observed as individuals change speed; effectively stressing their mobility.<br>|
| Children with Type 2 Diabetes<br>Chjildren with Type 2 Diabetes attending the Hospital Infantil de Mexico Federico Gomez, Mexico City, Mexico. | Diagnostic Test: Gait analysis<br>* Gait recorded using a sensor on the 4th vertebrae of the lumbar spine, once a week across 6 weeks during the routine PAIDOS clinic. Critical changes in walking control, stride frequency and length will be observed as individuals change speed; effectively stressing their mobility.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait | Critical changes in walking control, stride frequency and length observed as individuals change speed using a movement sensor (Inertial Measurement Units (IMU) on the 4th vertebrae of the lumbar spine). Recorded during a 10 metre walk and 6 minute walk test | 6 weeks, 3 and 6 month post-baseline follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 Minute Walk test (6MWT) | Distance traveled during the 6MWT in metres | 6 weeks, 3 and 6 month post-baseline follow-up | 
| Borg scale of perceived exertion | Recorded during the 6MWT | 6 weeks, 3 and 6 month post-baseline follow-up | 
| Heart rate | Number of beats per minute (BPM) recorded before and after the 6MWT. Determination by palpation of radial, brachial, carotid, or other pulse or by auscultation in precordial area using a stethoscope. | 6 weeks, 3 and 6 month post-baseline follow-up | 
| Respiratory rate | Recorded before and after the 6MWT. | 6 weeks, 3 and 6 month post-baseline follow-up | 
| O2 saturation (mmHg) using a pulse Oximeter | Recorded before and after the 6MWT. | 6 weeks, 3 and 6 month post-baseline follow-up | 
| Blood Pressure (mmHg) using a baumanometer | Recorded before and after the 6MWT | 6 weeks, 3 and 6 month post-baseline follow-up | 
| Insulin | Measured in microUnit/milliliter (McU/mL) of blood. | 6 weeks, 3 and 6 month post-baseline follow-up | 
| Fasting blood Glucose | Level of glucose after 12 hours fasting (overnight) measured in milligram/deciliter (mg/dL) of blood. | 6 weeks, 3 and 6 month post-baseline follow-up | 
| Hemoglobin A1C | Also known as glycated hemoglobin test, and glycohemoglobin. Measured in milligram/deciliter (mg/dL) of blood. | 6 weeks, 3 and 6 month post-baseline follow-up | 
| Total cholesterol | Measured in milligram/deciliter (mg/dL) of blood. | 6 weeks, 3 and 6 month post-baseline follow-up | 
| Level of High-density lipoprotein (HDL) in blood | Measured in milligram/deciliter (mg/dL) of blood. | 6 weeks, 3 and 6 month post-baseline follow-up | 
| Low-density lipoprotein (LDL) | Measured in milligram/deciliter (mg/dL) of blood. | 6 weeks, 3 and 6 month post-baseline follow-up | 
| Triglycerides | Measured in milligram/deciliter (mg/dL) of blood. | 6 weeks, 3 and 6 month post-baseline follow-up | 
| Alanine aminotransferase (ALT) | Measured in microUnit/milliliter (McU/mL) of blood. | 6 weeks, 3 and 6 month post-baseline follow-up | 
| Aspartate aminotransferase (AST) | Measured in millimoles Per Litre (mmol/L). | 6 weeks, 3 and 6 month post-baseline follow-up | 
| Homeostatic model assessment (HOMA) Index | Index that allows the re-estimation of insulin resistance and Beta cell function through glucose concentration and plasma insulin during fasting state. | 6 weeks, 3 and 6 month post-baseline follow-up | 
| Body Mass Index (BMI)- Kg/m2 |  | 6 weeks, 3 and 6 month post-baseline follow-up | 
| Hip Circumference | Maximum perimeter of the hips at the gluteal level in centimeters (cm) using a tape measure. | 6 weeks, 3 and 6 month post-baseline follow-up | 
| Waist Circumference | Maximum circumference of the horizontal line between the last rib and the superior iliac crest in centimetres (cm) using a tape measure. | 6 weeks, 3 and 6 month post-baseline follow-up | 
| Height | Centimeters (cm) | Baseline- Week 1 | 
| Weight | Kilograms (Kg) | 6 weeks, 3 and 6 month post-baseline follow-up | 
| Leg Length | The distance from the anterior superior iliac spine to the medial malleolus in centimetres (cm) using a tape measure. | Baseline- Week 1 | 
| Shoe Size | Mexican Shoe Size (length of foot in centimeters (cm) using a tape measure). | Baseline- Week 1 | 
| Physical Activity- Accelerometer | Axivity AX3 Monitors | 6 weeks | 
| Health Behaviour in School Aged Children (HSBC)- Eating Habits Questionnaire | Two multiple choice questions. 1 question assesses the frequency of breakfast consumption during weekdays and weekends. For weekdays- scores range from 1 (I never have breakfast during weekdays) - 6 (Five days). For weekends scores range from 1 (I never have breakfast during the weekend) to 3 (I usually have breakfast on both weekend days (Saturday AND Sunday). The higher the score the better the outcome. 1 question assesses food consumption frequency of fruit, vegetables, sweets and soft drinks that contain sugar.Scores range from 1 (Never) to 7 (Every day, more than once). Higher scores on fruit and vegetables = better outcome. The higher the score on sweets and soft drinks the worse the outcome. | 6 weeks |