## Protocol Section
### Identification Module
**NCT ID:** NCT01220479

**Acronym:** Diabex

**Brief Title:** Exercise Training Intervention in Children With Type 1 Diabetes

**Official Title:** Impact of an Exercise Training Program on Bone Development and Cardiovascular Disease Risk Factors in Children With Type 1 Diabetes Mellitus

#### Organization Study ID Info
**ID:** snf n°63164
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Geneva
### Status Module
#### Completion Date
**Date:** 2009-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2010-10-14

**Type:** ESTIMATED

**Last Update Submit Date:** 2010-10-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-12

**Type:** ACTUAL

#### Start Date
**Date:** 2001-09

**Status Verified Date:** 2010-10

#### Study First Post Date
**Date:** 2010-10-14
**Type:** ESTIMATED
**Study First Submit Date:** 2010-05-04
**Study First Submit QC Date:** 2010-10-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Swiss National Science Foundation

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Geneva

#### Responsible Party

**Old Name Title:** Farpour-Lambert Nathalie

**Old Organization:** University Hospital of Geneva

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Type 1 Diabetes Mellitus

**Keywords:**

- Type 1 Diabetes, Bone mineral density, Growth

- Cardiovascular diseases, Exercise, Training,

- Child, Adolescent

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 59

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Behavioral: Exercise training program

**Label:** Control Healthy

**Type:** NO_INTERVENTION

#### Arm Group 2

**Intervention Names:**

- Behavioral: Exercise training program

**Label:** Control Diabetic

**Type:** NO_INTERVENTION

#### Arm Group 3

**Intervention Names:**

- Behavioral: Exercise training program

**Label:** Exercise Diabetic

**Type:** EXPERIMENTAL

#### Arm Group 4

**Intervention Names:**

- Behavioral: Exercise training program

**Label:** Exercise Healthy

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control Diabetic

- Control Healthy

- Exercise Diabetic

- Exercise Healthy

**Description:** 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.

**Name:** Exercise training program

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Bone mineral density and content

**Time Frame:** Baseline

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

**Measure:** Bone mineral density and content

**Time Frame:** at 9 months

#### Secondary Outcomes

**Description:** Body weight, height, body mass index and pubertal stage

**Measure:** Anthropometrics

**Time Frame:** Baseline

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

**Measure:** Blood lipids levels

**Time Frame:** Baseline

**Description:** Physical activity level by questionnaire and accelerometer

**Measure:** Physical activity

**Time Frame:** Baseline

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

**Measure:** Nutrition

**Time Frame:** Baseline

**Description:** 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)

**Measure:** Circulating bone biomarkers levels

**Time Frame:** Baseline

**Description:** capillary HbA1c levels

**Measure:** Glycated Haemoglobin

**Time Frame:** Baseline

**Description:** Resting and 24-hour ambulatory systemic blood pressure monitoring

**Measure:** Systemic blood pressure

**Time Frame:** Baseline

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

**Measure:** Body composition

**Time Frame:** Baseline

**Description:** Body weight, height, body mass index and pubertal stage

**Measure:** Anthropometrics

**Time Frame:** at 9 months

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

**Measure:** Blood lipids levels

**Time Frame:** at 9 months

**Description:** Physical activity level by questionnaire and accelerometer

**Measure:** Physical activity

**Time Frame:** at 9 months

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

**Measure:** Nutrition

**Time Frame:** at 9 months

**Description:** 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)

**Measure:** Circulating bone biomarkers levels

**Time Frame:** at 9 months

**Description:** capillary HbA1c levels

**Measure:** Glycated Haemoglobin

**Time Frame:** at 3 months

**Description:** capillary HbA1c levels

**Measure:** Glycated Haemoglobin

**Time Frame:** at 6 months

**Description:** capillary HbA1c levels

**Measure:** Glycated Haemoglobin

**Time Frame:** at 9 months

**Description:** Resting and 24-hour ambulatory systemic blood pressure monitoring

**Measure:** Systemic blood pressure

**Time Frame:** at 9 months

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

**Measure:** Body composition

**Time Frame:** at 9 months

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 16 Years

**Minimum Age:** 8 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Geneva

**Country:** Switzerland

**Facility:** University Hospital of Geneva

**Zip:** 1205

#### Overall Officials

**Official 1:**

**Affiliation:** University Hospital, Geneva

**Name:** Farpour-Lambert Nathalie, PD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Maggio AB, Rizzoli RR, Marchand LM, Ferrari S, Beghetti M, Farpour-Lambert NJ. Physical activity increases bone mineral density in children with type 1 diabetes. Med Sci Sports Exerc. 2012 Jul;44(7):1206-11. doi: 10.1249/MSS.0b013e3182496a25.

**PMID:** 22246217

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes Mellitus

- ID: M7117

- Name: Diabetes Mellitus, Type 1

- Relevance: HIGH

- As Found: Type 1 Diabetes

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000003922

- Term: Diabetes Mellitus, Type 1

### Misc Info Module

- Version Holder: 2024-05-24
