NCT03814512Completed
Improving Insulin Resistance and Energy Metabolism Through Sleep Extension in Adolescents
Improving Insulin Resistance and Energy Metabolism Through Sleep Extension in Adolescents: The REM Study
Source: ClinicalTrials.gov · Last updated 1 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 22 Jan 2019
- Start date
- 21 Mar 2019
- Primary completion date
- 20 Apr 2022
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Type 2 diabetes
- NCT number
- NCT03814512
What you commit to
- Study type: Interventional
- Participants enrolled: 10
- From 21 Mar 2019 to the primary completion date, 20 Apr 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any medications that affect insulin resistance or sleep (e.g., metformin, stimulants, atypical antipsychotics, current use of oral steroids)
- 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
- Travel across more than two time zones in the 2 weeks prior to the study
Other illness
- IQ\<70 or severe mental illness that may impact sleep or ability to consent/assent (e.g., schizophrenia, psychotic episodes), verified through chart review
Lab values
- Type 2 diabetes (HbA1c ≥ 6.5%)
Other
- Regular use of melatonin or other sleep aids
- Teens not enrolled in a traditional high school academic program (e.g., home school students)
- Schedules that would preclude participants from adhering to the sleep extension protocol (e.g. night shift employment)
Who the study is looking for
- High school students between the age of 13-19 years
- BMI \>85th percentile for age and sex
- Prediabetes defined as a HbA1c 5.7-6.4%
- Tanner Stage 4-5 (based on breast development for girls and testicular size for boys)
Age in the registry: 13 years to 19 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital Colorado Coordinator of this site? Confirm its status | Lafayette | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.