Exercise Training Intervention in Children With Type 1 Diabetes

N/ACompletedNCT01220479

University Hospital, Geneva59 enrolled

Overview

Type 1 diabetes mellitus (T1DM) is associated with multiple co-morbidities, such as hypertension, dyslipidemia, coronary heart disease and osteoporosis. The foundation of these conditions lays in childhood. Exercise is known to have a positive influence on bone mineral density (BMD) and some impact on cardiovascular disease risk factors in healthy children, but little is known about these associations in children with T1DM. The main purpose of this study is to assess the effects of a 9-month weight-bearing exercise training program on skeletal development in children with T1DM, compared to healthy subjects. The second aim is to evaluate whether the program influences also cardiovascular diseases risk factors. This is a randomized controlled study incorporating 30 children with T1DM and 30 healthy children. Both groups are randomly divided (1:1) in an exercise or a control group: 1) exercise diabetic, 2) controls diabetic, 3) exercise healthy, 4) controls healthy. Exercise groups participate to an identical weight-bearing exercise training program 2 x 90 minutes per week and controls are relatively inactive. Main measures include: total body, lumbar spine and hip BMD by DXA, body fat and fat-free mass, bone biomarkers levels, resting and ambulatory blood pressure and fasting blood lipids.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Type 1 Diabetes Mellitus

Interventions

Exercise training programBEHAVIORAL

Exercise Diabetic and Healthy groups perform a similar training program including two exercise sessions per week, of 90 minutes each, during 9 months (excluding holidays) under supervision by physical education teachers and pediatricians. Sessions comprise various weight-bearing activities: rope skipping, jumping, ball games and gymnastics. Control groups are relatively inactive.

Eligibility

Sex: ALLMin age: 8 YearsMax age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

List of inclusion criteria for Type 1 diabetes patients: 1\) disease for at least 1 year. List of inclusion criteria for healthy subjects: 1\) good general health and normal growth. List of exclusion Criteria for all subjects: 1. presence of other chronic disease, including thyroid disease; 2. medications, hormones other than insulin, or calcium preparations taken in the preceding 6 months; 3. presence of nephropathy; 4. systemic disease or hospitalization for more than 2 weeks in the preceding year; 5. less than 6 menstrual cycles in the past year for post-menarche girls; 6. participation in competitive sport.

Locations (1)

University Hospital of Geneva

Geneva, Canton of Geneva, Switzerland

Outcomes

Primary Outcomes

Bone mineral density and content

Assessment of bone mineral density (BMD) and content (BMC) at the whole body, hip and lumbar spine using DXA.

Time frame: Baseline

Bone mineral density and content

Assessment of bone mineral density (BMD) and content (BMC) at the whole body, hip and lumbar spine using DXA.

Time frame: at 9 months

Secondary Outcomes

Anthropometrics

Body weight, height, body mass index and pubertal stage

Time frame: Baseline

Blood lipids levels

Fasting total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides, lipoprotein (a), apolipoproteins A-I and B levels.

Time frame: Baseline

Physical activity

Physical activity level by questionnaire and accelerometer

Time frame: Baseline

Nutrition

Total energy, proteins, lipids, carbohydrates and calcium intakes using food records

Time frame: Baseline

Circulating bone biomarkers levels

Serum levels of beta-CrossLaps (CTX), N-MID-Osteocalcin (OC), N-Terminal Propeptide of Type I Collagen (PINP) and 25-OH-vitamin D (25-OH-D)

Time frame: Baseline

Glycated Haemoglobin

capillary HbA1c levels

Time frame: Baseline

Systemic blood pressure

Resting and 24-hour ambulatory systemic blood pressure monitoring

Time frame: Baseline

Body composition

Assessment of whole body and abdominal fat mass, and total fat-free mass using DXA.

Time frame: Baseline

Anthropometrics

Body weight, height, body mass index and pubertal stage

Time frame: at 9 months

Blood lipids levels

Fasting total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides, lipoprotein (a), apolipoproteins A-I and B levels.

Time frame: at 9 months

Physical activity

Physical activity level by questionnaire and accelerometer

Time frame: at 9 months

Nutrition

Total energy, proteins, lipids, carbohydrates and calcium intakes using food records

Time frame: at 9 months

Circulating bone biomarkers levels

Serum levels of beta-CrossLaps (CTX), N-MID-Osteocalcin (OC), N-Terminal Propeptide of Type I Collagen (PINP) and 25-OH-vitamin D (25-OH-D)

Time frame: at 9 months

Glycated Haemoglobin

capillary HbA1c levels

Time frame: at 3 months

Glycated Haemoglobin

capillary HbA1c levels

Time frame: at 6 months

Glycated Haemoglobin

capillary HbA1c levels

Time frame: at 9 months

Systemic blood pressure

Resting and 24-hour ambulatory systemic blood pressure monitoring

Time frame: at 9 months

Body composition

Assessment of whole body and abdominal fat mass, and total fat-free mass using DXA.

Time frame: at 9 months

Data from ClinicalTrials.gov

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