CLINICAL TRIAL

Treatment for Glucose

Recruiting · 18 - 65 · All Sexes · Boston, MA

This study is evaluating whether melatonin and a specific gene variation may be related to blood sugar regulation.

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About the trial for Glucose

Eligible Conditions
Glucose · Genes · Melatonin · Circadian Rhythms

Treatment Groups

This trial involves a single treatment. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex between 18 and 65 years old. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Body Mass Index: 20 and 35 kg/m2
Age: 21-55 years of age
Caucasian
Non-smoking
With regular sleep-wake cycle
Passed medical and psychological screening tests
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Day 2, 3, 4 and/or 5 of the in-lab protocol
Screening: ~3 weeks
Treatment: Varies
Reporting: Day 2, 3, 4 and/or 5 of the in-lab protocol
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Day 2, 3, 4 and/or 5 of the in-lab protocol.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 1 primary outcome and 3 secondary outcomes in patients with Glucose. Measurement will happen over the course of Day 2 and/or 4 of the in-lab protocol.

change in disposition index
DAY 2 AND/OR 4 OF THE IN-LAB PROTOCOL
Disposition index will be determined by frequently sampled intravenous glucose tolerance test
DAY 2 AND/OR 4 OF THE IN-LAB PROTOCOL
change in glucose tolerance
DAY 2, 3, 4 AND/OR 5 OF THE IN-LAB PROTOCOL
DAY 2, 3, 4 AND/OR 5 OF THE IN-LAB PROTOCOL
change in insulin sensitivity
DAY 2, 3, 4 AND/OR 5 OF THE IN-LAB PROTOCOL
DAY 2, 3, 4 AND/OR 5 OF THE IN-LAB PROTOCOL
change in first-phase insulin release
DAY 2, 3, 4 AND/OR 5 OF THE IN-LAB PROTOCOL
DAY 2, 3, 4 AND/OR 5 OF THE IN-LAB PROTOCOL

Who is running the study

Principal Investigator
F. A. S.
Prof. Frank AJL Scheer, PhD
Brigham and Women's Hospital

Patient Q & A Section

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

How many people get melatonin a year in the United States?

Findings from a recent study of this study are reassuring given the lack of data on melatonin use by pregnant women and children. In a cohort of almost 60,000 newborns, melatonin use is a well-established treatment given at the request of mothers for sleep-related disorders associated with infant feeding.

Anonymous Patient Answer

What causes melatonin?

Melatonin is very abundant in body tissues, especially in the pineal gland. Most melatonin is synthesized in the liver, but many tissues contain adrenal cortex cells that store it at high levels, particularly in the brain. The effects of melatonin are not limited to its regulation of circadian rhythms, but other roles have also been identified. In a large population study, the levels of melatonin were found to be decreased in schizophrenia. It is possible that there is a relationship between melatonin, schizophrenia and neuropsychiatric disorders.

Anonymous Patient Answer

What is melatonin?

In summary, melatonin is one of the major anti-aging hormones. It protects the organism during aging as it inhibits oxidative damages. It also helps in cellular survival and apoptosis and has the capability of regulating hormonal levels.

Anonymous Patient Answer

What are the signs of melatonin?

In a healthy individual, the main body clock is functioning normally and if there are no other signs, then the cause of the disrupted sleep or sleep-wake cycle is not obviously melatonin. But if the patient is still very sleepy and has other symptoms that appear similar; then it is recommended that their melatonin levels are checked. Melatonin was discovered when it was found that one night at bedtime, an adult would suffer insomnia, because they are not awakened as usual. So it was tested to see if that pattern was a normal response. For a sleeping disorder, there was no regular pattern to awaken first: it was found that the main problem was the sleep pattern before going to bed. The melatonin awakening was a remedy.

Anonymous Patient Answer

Can melatonin be cured?

When melatonin was assessed using this questionnaire there was a significant positive connection between the self perceived effect of melatonin and perceived healing with melatonin use. There wasn’t a single item assessed, nor a specific time point of response, so it’s too early to define if melatonin may be cured or not by using this questionnaire.

Anonymous Patient Answer

What are common treatments for melatonin?

Melatonin may be used to reduce anxiety and insomnia and may have antiallergic effects. Melatonin may be useful in the treatment of hyperprolactinaemia. Melatonin may have an antiallergic effect in patients with allergic rhinitis. Oral melatonin is used as a sedative. Oral melatonin for sleep and circadian rhythm function is effective in patients suffering from morningness, eveningness and chronic insomnia. The most common side effect is headache. Other possible side effects include light-headedness, drowsiness, dizziness, nausea, irritability and depression. Rarely, seizures have been reported. Melatonin has been given under the assumption of improvement in sleep quality but there is high variability in the effect of melatonin.

Anonymous Patient Answer

Has treatment proven to be more effective than a placebo?

Both the ACT and the LTP groups, who received the ACT or LTP as the only therapy, showed significant improvements in PSQI score and subjective sleep quality as compared to the PSQI scores of the placebo, indicating that both ACT treatment and LTP treatment are as effective as an ACT+placebo treatment, but with no advantage over the placebo.

Anonymous Patient Answer

Have there been other clinical trials involving treatment?

There are only two (two) clinical trials regarding the effect of melatonin on the treatment of non-24-hour sleep-wake disorder (NSWD). Although the trial result of this study is not statistically significant (p=0.05), the sleep onset latency of the treatment group, as the endpoint, is statistically significantly shorter than the placebo group. This treatment can be considered a viable option for NSWD. The treatment effect of melatonin on the NSWD is not statistically significant (p=0.057). This treatment is one of the viable options for NSWD Treatment The treatment effect of melatonin on the NSWD is more effective than benzodiazepines.

Anonymous Patient Answer

What is treatment?

If it is recommended to start at 4-5mg per night, it is necessary to have a daily schedule of taking melatonin. People using a melatonin-inhibitor do not need to be afraid of being treated, but people that already use it should refrain from it for four to seven days or longer.

Anonymous Patient Answer

What is the primary cause of melatonin?

The most reasonable conclusion is that melatonin is primarily a signal molecule to the body. It is present in our food, in milk, our milk and dairy products, in red blood cells, in our own body, and it is present in our sweat glands. It is present in our blood where it binds to receptors on the surface of monocytes, neutrophils and lymphocytes to signal the function of these cell types. And it is most likely also present in the brain. There is only one possible place in our biology where melatonin signaling is blocked by high levels of serotonin. This is in the blood-brain barrier where serotonin binds with an equal affinity to the receptors at the blood–brain barrier.

Anonymous Patient Answer

What is the latest research for melatonin?

Melatonin was not recommended for sleep disorders. In the present study we found that melatonin has a strong hypnotic effect and has a modest antidepressant or anxiolytic effect in insomnia subjects.

Anonymous Patient Answer

Have there been any new discoveries for treating melatonin?

There are many ways of getting melatonin, but no studies have been published that compare the effectiveness of different ways of doing so. Further research may shed light on more efficient ways of getting melatonin that will be more cost-effective for the long run.

Anonymous Patient Answer
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