Sleep and Type 1 Diabetes

NCT02494375 | Unknown

• 1 other identifier: 69HCL15_0219
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of the study is to determine whether insufficient sleep is associated with poor glycemic control in type 1 diabetic children. Secondary goals aim to determine whether salivary amylase could be an easily accessible and non-invasive biomarker of sleep loss and somnolence, and whether insufficient sleep is linked to body composition. Sleep characteristics, glycemic control, salivary amylase and body composition will be assessed 3 times, at 3-4 months intervals, in 82 type 1 diabetic children.

Conditions

Type 1 Diabetes

Keywords

Sleep; glycemic control; type 1 diabetes; amylase; body composition; lean; overweight; obese

Outcome Measures

Primary Outcomes (1)

• Association between HbA1c and sleep characteristics

  Month 3, Month 6 and Month 9

Secondary Outcomes (3)

• Glucose levels

  Month 3, Month 6 and Month 9

• Daily salivary amylase variation (Enzyme Activity)

  Month 3, Month 6 and Month 9

• Body composition (BMI fat and lean mass percentage)

  Month 3, Month 6 and Month 9

Study Arms (1)

Sleep and glucose assessement.

EXPERIMENTAL

Other: Sleep and glucose assessments

Interventions

Sleep and glucose assessments OTHER

Sleep characteristics, glycemic control, salivary amylase and body composition will be assessed 3 times, at 3-4 months intervals

Sleep and glucose assessement.

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- Female and male type 1 diabetic children and adolescents who are followed at the Woman, Mother and Child's Hospital (Hôpital Femme Mère Enfant : HFME) of Bron, France.

You may not qualify if:

• Refusal of consent of the parents or the child or the adolescent
• Pregnancy
• Concomitant pathology that severly impacts sleep
• Implanted electrical stimulation device
• Diagnosis of type 1 diabetes \<1 year

Sponsors & Collaborators

• Hospices Civils de Lyon: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69000, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Overweight; Obesity

Interventions

Sleep

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2015
• First Posted: July 10, 2015
• Study Start: June 28, 2015
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 5, 2020

Record last verified: 2020-10

Locations

FR (1)