Extended Sleep Intervention for Diabetes Mellitus, Type 2

Phase-Based Estimates
1
Effectiveness
1
Safety
Children's Hospital Colorado, Lafayette, CO
Diabetes Mellitus, Type 2+2 More
Extended Sleep Intervention - Behavioral
Eligibility
< 65
All Sexes
Eligible conditions
Diabetes Mellitus, Type 2

Study Summary

This study is evaluating whether a sleep extension intervention may have positive impacts for adolescents.

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Eligible Conditions

  • Diabetes Mellitus, Type 2
  • Insulin Resistance
  • Sleep

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Extended Sleep Intervention will improve 1 primary outcome in patients with Diabetes Mellitus, Type 2. Measurement will happen over the course of up to 12 weeks.

up to 12 weeks
Change in Total Sleep Time

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Extended Sleep Intervention (ES)

This trial requires 26 total participants across 2 different treatment groups

This trial involves 2 different treatments. Extended Sleep Intervention is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Extended Sleep Intervention (ES)
Behavioral
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.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 12 weeks for reporting.

Closest Location

Children's Hospital Colorado - Lafayette, CO

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The person is overweight for their age and sex. show original
A person is prediabetic if their HbA1c level is 5.7-6.4%. show original
old are required to attend school All high school students aged 13-19 are required to attend school. show original
The Tanner stage 4-5 is based on breast development for girls and testicular size for boys. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is diabetes mellitus, type 2?

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Diabetes mellitus, type 2 is the most common cause of non-alcoholic fatty liver disease (NAFLD), as well as being the most common cause of new cases of fatty liver disease. Diabetes mellitus type 2 accounts for approximately 75 percent of pancreatic and 90 percent of hepatic cancer cases.

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What are common treatments for diabetes mellitus, type 2?

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Common treatments for diabetes mellitus, also known as type 2 diabetes, include lifestyle treatments (diet and exercise), as well as drugs – metformin (to lower blood sugar) and other oral hypoglycemic medications. Insulin injections or insulin pump therapy are also commonly used to regulate blood sugar levels. These drugs are generally only used once a patient has had diabetes for a few years.

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Can diabetes mellitus, type 2 be cured?

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With aggressive, well-controlled management and treatment, many of the complications associated with DM2 can be largely avoided. However, the exact long-term prognosis is unclear, as little is known about the pathogenesis, prevention, and management of DM2.

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What are the signs of diabetes mellitus, type 2?

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In a recent study, findings indicate that routine screening for [diabetes type 2](https://www.withpower.com/clinical-trials/diabetes-type-2) detects previously undiagnosed diabetes with increased frequency compared to conventional screening practices. Based on these findings, we propose that a screening program incorporating diabetes type 2 into the preconception counseling of pregnant women be implemented.

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What causes diabetes mellitus, type 2?

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Approximately 90% of diabetes mellitus, type 2 is attributed to an accumulation of environmental and genetic factors. The environment of pregnancy, the perinatal period, and infancy appear to be the key elements in triggering insulin resistance, which is a hallmark of DM2.

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How many people get diabetes mellitus, type 2 a year in the United States?

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An estimated 35.7 million people have diabetes in the United States, and nearly 15 percent of those (4.7 million) have type 2 diabetes. The incidence of type 2 diabetes is predicted to more than double by 2025. Diabetes accounts for almost 17%, and nearly 11%, of new cases of heart disease in the United States. Diabetes also accounts for 25% of the cost of care for cardiovascular diseases and is the cause of approximately one third of the annual expenditure on diabetic eye diseases, which may escalate costs to a quarter to a third of the total. Current trends suggest that the incidence of type 2 diabetes will continue to increase.

Unverified Answer

What are the latest developments in extended sleep intervention for therapeutic use?

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Studies examining the efficacy of the treatment demonstrated that the patients enrolled in them did demonstrate improvements in depression, as well as in glycemic control. In addition, the treatment was reported to have minimal side-effects and there a good chance of long-term adherence. Further studies have confirmed the effectiveness of such treatment for people with T2DM.

Unverified Answer

What is the primary cause of diabetes mellitus, type 2?

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The majority of patients and physicians in this study would prefer the term 'diabetes, type 2' rather than 'diabetes' or 'prediabetes' to describe their condition. This suggests that patients and their physicians believe that it better reflects their experiences and the complexity of diabetes, which includes different causes and clinical characteristics.

Unverified Answer

Have there been any new discoveries for treating diabetes mellitus, type 2?

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There has been a large number of studies since 2013 on new therapies for treating diabetes mellitus, type 2. Many patients have no medication to control their blood sugar levels and find themselves prescribed a variety of medications for managing the disease. Withdrawal from many classes of medications usually brings the disease under control, unless there is a predisposition to complications such as diabetic ketoacidosis or diabetic nephropathy. However many medications in use today are efficacious with minimal side effects and provide a good control of blood sugar levels in patients who adhere to the correct regimen.

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Has extended sleep intervention proven to be more effective than a placebo?

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A 7-week treatment with an extended sleep intervention significantly improved glycemic control and cardiovascular risk when comparing it with a placebo in a cohort of patients with diabetes, hypertension and coronary heart disease.

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Who should consider clinical trials for diabetes mellitus, type 2?

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Clinicians of patients with T2DM should consider clinical trial enrollment based on their willingness to pay, since clinical trials provide important information about drug benefits. Patients with T2DM should also consider clinical trial enrollment in light of their willingness to receive an acceptable risk of serious disease.

Unverified Answer

What does extended sleep intervention usually treat?

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It is a safe and effective treatment option for patients with type 2 diabetes as a result of limited sleep. One must be aware that extended sleep interventions may not be beneficial for the patients with type 2 diabetes who suffer from other complications such as hypertension. Moreover, some of the patients with type 2 diabetes may develop hypoglycemia during prolonged sleep interventions and it is recommended to control blood sugar to prevent hypoglycemia during sleep interventions.

Unverified Answer
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Get access to this novel treatment for Diabetes Mellitus, Type 2 by sharing your contact details with the study coordinator.