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NCT04642313 Clinical Trial

Comparison of Mg Vs. K Supplementation on Insomnia in Diabetics

Focus of Study is on Insomnia Among Diabetic Patients Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04642313
Other study ID # UOL-UIDNS-Mg-K
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 26, 2020
Est. completion date April 26, 2022

Study information
Verified date November 2020
Source University of Lahore
Contact Sidra Khalid
Phone 0923347498338
Email sidrakhalid.uaf@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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: 1. To compare the effect of magnesium and/ or potassium on insomnia patients with diabetes mellitus 2. To compare the gender and age based response to magnesium and/ or potassium on insomnia patients with diabetes mellitus 3. To compare the effect of magnesium and/ or potassium on insulin resistance among insomnia patients with diabetes mellitus 4. To compare the effect of magnesium and/ or potassium on sleep hormones among insomnia patients with diabetes mellitus 5. To compare the effect of magnesium and/ or potassium on serum electrolytes (Mg, K) among insomnia patients with diabetes mellitus 6. 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

Recruitment information / eligibility
Status Recruiting
Enrollment 320
Est. completion date April 26, 2022
Est. primary completion date April 26, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

  • Focus of Study is on Insomnia Among Diabetic Patients
  • Sleep Initiation and Maintenance Disorders

Intervention

Other:
• Magnesium and/ or Potassium
Magnesium and/ or potassium supplements will be provided to patients of diabetes mellitus with insomnia

Locations
Country Name City State
Pakistan Akhuwat Health Services Lahore Punjab
Pakistan The University of Lahore Lahore Punjab

Sponsors (1)
Lead Sponsor Collaborator
University of Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Other 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 60 Days
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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