An interventional study of Magnesium and/ or Potassium in Focus of Study is on Insomnia Among Diabetic Patients, sponsored by University of Lahore. Status unknown at 2 sites in Pakistan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-11-24.
Sponsored by University of Lahore · Not applicable, Interventional, and Treatment
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.
Sleep is the essential component to maintain good health of an individual. Insomnia is defined as a condition that affects an individual by inability to get sufficient quality sleep or problem in maintaining sleep that is important for healthy functioning, performance and well being. Insomnia can exist in healthy individual or comorbidly with other medical diseases. Latest researches indicate that intolerance of glucose in the body, resistance to insulin hormone, decreased acute response of insulin to glucose and increased chances of having type 2 diabetes are reasons for reduced or interrupted sleep. Several electrolytes and minerals influence the sleep cycle. Magnesium is important in regulation of central nervous system excitability, through ion channel conductivity. Magnesium is a muscle relaxant and inducer of the deeper sleep. Hypomagnesemia is a common feature in patients with type 2 diabetes. Although diabetes can induce hypomagnesemia, magnesium deficiency has also been proposed as a risk factor for type 2 diabetes. Magnesium supplementation improves sleep efficiency, sleep time and sleep onset latency, early morning awakening, and insomnia objective measures such as the concentration of serum renin, melatonin, and serum cortisol, in older adults. High ambient potassium levels have been shown to shorten the period of circadian rhythms in a variety of organisms. Little is known about the effects of dietary mineral nutrients on human sleep quality. Potassium depletion has been shown to cause glucose intolerance, which is associated with impaired insulin secretion . Recently, there has been growing evidence from both animal and human studies indicating that high sodium and low potassium intakes are associated with a high risk of insulin resistance or diabetes.
The Study is aimed to:
Inclusion Criteria:
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's planned enrollment of 320 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →University of Lahore is the lead sponsor of 223 studies on the registry; 40 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients of diabetes mellitus with insomnia
Exclusion Criteria:
Individuals with the following conditions will not be included as participants, patients of diabetes mellitus with insomnia with
Placebo treatment: starch tablets (250 mg)
Other: Magnesium and/ or Potassium
Magnesium group: Magnesium gluconate (250 mg)
Other: Magnesium and/ or Potassium
Potassium group: Potassium chloride (250 mg)
Other: Magnesium and/ or Potassium
Magnesium + Potassium group: Magnesium gluconate (250 mg) + Potassium chloride (250 mg)
Other: Magnesium and/ or Potassium
Magnesium and/ or potassium supplements will be provided to patients of diabetes mellitus with insomnia
Effects of magnesium and/ or potassium supplementation on insomnia severity patients with diabetes mellitus
Insomnia Severity Index (ISI) will be used to assess and categorize the insomnia among patients with diabetes mellitus, before and after the intervention
Time frame: 60 days
Effects of magnesium and/ or potassium on insulin resistance among insomnia patients with diabetes mellitus
Homeostatic model assessment for insulin resistance (HOMA-IR) will be used to measure the insulin resistance before and after the Mg, K supplementation among insomniac patients with diabetes mellitus. Insulin will be measured through ELISA technique.
Time frame: 60 days
Effects of magnesium and/ or potassium on sleep hormones (melatonin, cortisol) among insomniac patients with diabetes mellitus.
Sleep hormones (melatonin, cortisol) will be measured before and after the intervention, through ELISA technique, among insomniac patients with diabetes mellitus.
Time frame: 60 days
Effect of magnesium and/ or potassium on serum electrolytes (Mg, K) among insomnia patients with diabetes mellitus
Serum magnesium and/ potassium (in blood) will be measured through chemistry analyzer, before and after the Mg, K supplementation among insomniac patients with diabetes mellitus
Time frame: 60 days
Effect of magnesium and/ or potassium on quality of life (QOL) among insomnia patients with diabetes mellitus
WHOQOL-BREF will be used to measure quality of life before and after the Mg, K supplementation, among insomniac patients with diabetes mellitus.
Time frame: 60 days
Gender and age based response to magnesium and/ or potassium on insomnia patients with diabetes mellitus
Gender and age based responses of Mg, K supplementation will be compared among insomniac patients with diabetes mellitus
Time frame: 60 days
Effect of magnesium and/ or potassium on quality liver function tests (LFTs) among insomnia patients with diabetes mellitus
Liver function tests (ALT, AST) will measured before and after the Mg, K supplementation among insomniac patients with diabetes mellitus
Time frame: 60 Days
Plan to share: No — Patients data will be kept confidential and their identity will not be revealed
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sleep Initiation and Maintenance Disorders→
University of Lahore