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Improving Insulin Resistance and Energy Metabolism Through Sleep Extension in Adolescents (REM)

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ClinicalTrials.gov Identifier: NCT03814512
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
The investigators propose to deliver a 4-week sleep extension intervention to adolescents to evaluate feasibility of the protocol and obtain preliminary data on intra-individual changes in metabolic parameters induced by sleep extension.

Condition or disease Intervention/treatment Phase
Sleep Diabetes Mellitus, Type 2 Behavioral: Extended Sleep Intervention Not Applicable

Detailed Description:

The specific aims of this feasibility study are to 1) examine the feasibility of recruitment and retention of adolescents with overweight/obesity, pre-diabetes, and inadequate sleep into a sleep extension intervention; 2) assess adherence of a sleep extension intervention to increase total sleep time in adolescents with overweight/obesity, pre-diabetes, and inadequate sleep; 3) determine estimates of mean and variability of potential intervention outcomes including metabolomic, body composition, and substrate oxidation. The investigators propose to deliver a 4-week sleep extension intervention to adolescents to evaluate feasibility of the protocol and obtain preliminary data on intra-individual changes in metabolic parameters induced by sleep extension.

This proposal is the first step to demonstrate feasibility in delivering the intervention in a research setting, measure the effect of the intervention on changing sleep duration, and examine changes in obesity-related IR metabolites that would lead to improved IR in an adolescent population with pre-diabetes. The long-term goal is to disseminate an effective and feasible T2D prevention program that can be sustainably implemented in clinical weight management settings.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is a pilot study testing the intervention arm of the RCT. No control group.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Improving Insulin Resistance and Energy Metabolism Through Sleep Extension in Adolescents: The REM Study
Actual Study Start Date : March 21, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: Extended Sleep Intervention (ES)
Participants will receive a Standard Care Diet and Physical Activity Education Intervention (SC) and an Extended Sleep Intervention (ES). For the SC, participants will have their diet, physical activity, and screen time assessed by study interventionist. Prescribed goals will be determined collaboratively through discussion with participants and parents. For the ES, participants will subsequently be prescribed a sleep schedule that allows them to obtain 1.5 h more time in bed compared to their typical sleep. Prescribed bedtimes and wake times will be determined collaboratively.
Behavioral: Extended Sleep Intervention
Participants will receive an Extended Sleep Intervention (ES). Participants will be prescribed a sleep schedule that allows them to obtain approximately 1.5 h more time in bed compared to their typical sleep. Prescribed bedtimes and wake times will be determined collaboratively through discussion with participants and parents.




Primary Outcome Measures :
  1. Change in Total Sleep Time [ Time Frame: up to 12 weeks ]
    The amount of time (hours:minutes) the participant sleeps post-intervention compared to pre-intervention



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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. High school students between the age of 13-19 years
  2. BMI >85th percentile for age and sex
  3. Prediabetes defined as a HbA1c 5.7-6.4%
  4. Tanner Stage 4-5 (based on breast development for girls and testicular size for boys)

Exclusion Criteria:

  1. Any medications that affect insulin resistance or sleep (e.g., metformin, stimulants, atypical antipsychotics, current use of oral steroids)
  2. Regular use of melatonin or other sleep aids
  3. A prior diagnosis of a sleep disorder (e.g. insomnia, delayed sleep phase syndrome, obstructive sleep apnea) or abnormal scores on sleep disorders screening measures
  4. Type 2 diabetes (HbA1c ≥ 6.5%)
  5. IQ<70 or severe mental illness that may impact sleep or ability to consent/assent (e.g., schizophrenia, psychotic episodes), verified through chart review
  6. Teens not enrolled in a traditional high school academic program (e.g., home school students)
  7. Schedules that would preclude participants from adhering to the sleep extension protocol (e.g. night shift employment)
  8. Travel across more than two time zones in the 2 weeks prior to the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03814512


Contacts
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Contact: Jill L Kaar, PhD 7207773571 jill.kaar@ucdenver.edu
Contact: Wesley Pendleton 720-777-5974 Wesley.Pendleton@childrenscolorado.org

Locations
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United States, Colorado
Children's Hospital Colorado Recruiting
Lafayette, Colorado, United States, 80026
Contact: Jill Kaar, PhD    720-777-3571    jill.kaar@ucdenver.edu   
Sponsors and Collaborators
University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03814512     History of Changes
Other Study ID Numbers: 18-2396
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Insulin Resistance
Diabetes Mellitus, Type 2
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs