Comparison of Mg Vs. K Supplementation on Insomnia in Diabetics

Study Overview
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Brief Summary
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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.

Detailed Description
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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: To compare the effect of magnesium and/ or potassium on insomnia patients with diabetes mellitus To compare the gender and age based response to magnesium and/ or potassium on insomnia patients with diabetes mellitus To compare the effect of magnesium and/ or potassium on insulin resistance among insomnia patients with diabetes mellitus To compare the effect of magnesium and/ or potassium on sleep hormones among insomnia patients with diabetes mellitus To compare the effect of magnesium and/ or potassium on serum electrolytes (Mg, K) among insomnia patients with diabetes mellitus To compare the effect of magnesium and/ or potassium on quality of life (QOL) among insomnia patients with diabetes mellitus MATERIAL AND METHODS Study Design: Randomized Controlled Trial (single blind) Settings: Study will be conducted at 1. Akhuwat Health Services, Lahore Duration of Study: 18 months (after the approval of synopsis) Sample Size: is 280 and with expected 20% drop out: 320 Sampling Technique: Non probability purposive sampling 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 antidiabetic drugs

Official Title
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Comparison of Magnesium Versus Potassium and Their Combined Effect on Insomnia, Sleep Hormones, Insulin Resistance and Quality of Life Among Patients With Diabetes Mellitus.

Conditions
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Focus of Study is on Insomnia Among Diabetic Patients

Intervention / Treatment
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* Other: Magnesium and/ or Potassium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be divided into 4 groups and will receive 4 different treatments at same time
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: PLACEBO group<br>Placebo treatment: starch tablets (250 mg) | Other: Magnesium and/ or Potassium<br>* Magnesium and/ or potassium supplements will be provided to patients of diabetes mellitus with insomnia<br>|
| Experimental: Magnesium group<br>Magnesium group: Magnesium gluconate (250 mg) | Other: Magnesium and/ or Potassium<br>* Magnesium and/ or potassium supplements will be provided to patients of diabetes mellitus with insomnia<br>|
| Experimental: Potassium group<br>Potassium group: Potassium chloride (250 mg) | Other: Magnesium and/ or Potassium<br>* Magnesium and/ or potassium supplements will be provided to patients of diabetes mellitus with insomnia<br>|
| Experimental: Magnesium + Potassium group<br>Magnesium + Potassium group: Magnesium gluconate (250 mg) + Potassium chloride (250 mg) | Other: Magnesium and/ or Potassium<br>* Magnesium and/ or potassium supplements will be provided to patients of diabetes mellitus with insomnia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | 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 | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Diabetes Mellitus, Magnesium, Potassium, Melatonin, Cortisol, Insulin resistance, Quality of Life