Comparison of Mg Vs. K Supplementation on Insomnia in Diabetics (NCT04642313) | Clinical Trial Compass
UnknownNot Applicable
Comparison of Mg Vs. K Supplementation on Insomnia in Diabetics
Pakistan320 participantsStarted 2020-10-26
Plain-language summary
Insomnia is increasing alarmingly among the population. Micronutrient fluctuations have been shown to effect insulin secretion, period of circadian cycle and quality of sleep in all ages. This study is aimed to identify the impact of magnesium and potassium supplementation on insomnia severity and duration, and insulin resistance, quality of life, sleep hormones, serum magnesium and potassium levels. Moreover, the study will help to find out the link between insomnia and micronutrients among patients of diabetes mellitus so that the burden of the disease in the society could be reduced.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* • Patients of diabetes mellitus with insomnia
* Adult diabetic patients aged between 19 to 65 years
* Patients of both genders
* Diabetic patients of insomnia with or without anti-diabetic drugs
* Diabetic patients of insomnia with or without Hypomagnesaemia
* Diabetic patients of insomnia with or without Hypokalemia
Exclusion Criteria:
* Individuals with the following conditions will not be included as participants, patients of diabetes mellitus with insomnia with
* Psychiatry reasons
* Any hormonal treatment
* CVD/ Other metabolic co-morbidities
* History of acute liver injury (e.g., hepatitis) or severe cirrhosis
* Renal diseases (renal stones, renal failure, dialysis)
* Diabetic nephropathy
* Pregnancy
* Breast-feeding
* Drug induced insomnia
* Sleep disorders
* Sleep-related movement disorders (restless leg syndrome)
* Sleep-related respiratory disorders (sleep apnea)
* Alcohol consumption
* Cardiac respiratory disorders
* Painful condition (apathy)
* History of chronic liver disease
* History of CKD
* Participation in a study of an investigational medication or nutritional supplements/ medication within the past 90 days
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effects of magnesium and/ or potassium supplementation on insomnia severity patients with diabetes mellitus
Timeframe: 60 days
2
Effects of magnesium and/ or potassium on insulin resistance among insomnia patients with diabetes mellitus
Timeframe: 60 days
3
Effects of magnesium and/ or potassium on sleep hormones (melatonin, cortisol) among insomniac patients with diabetes mellitus.
Timeframe: 60 days
4
Effect of magnesium and/ or potassium on serum electrolytes (Mg, K) among insomnia patients with diabetes mellitus