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Comparison of Mg Vs. K Supplementation on Insomnia in Diabetics

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ClinicalTrials.gov Identifier: NCT04642313
Recruitment Status : Recruiting
First Posted : November 24, 2020
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Sidra Khalid, University of Lahore

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Focus of Study is on Insomnia Among Diabetic Patients Other: Magnesium and/ or Potassium Not Applicable

Detailed 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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be divided into 4 groups and will receive 4 different treatments at same time
Masking: Single (Participant)
Masking Description: It will be single blind study, Participants will not be aware of the treatment group, they are receiving
Primary Purpose: Treatment
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".
Actual Study Start Date : October 26, 2020
Estimated Primary Completion Date : April 26, 2021
Estimated Study Completion Date : April 26, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: PLACEBO group
Placebo treatment: starch tablets (250 mg)
 Other: Magnesium and/ or Potassium
Magnesium and/ or potassium supplements will be provided to patients of diabetes mellitus with insomnia
Experimental: Magnesium group
Magnesium group: Magnesium gluconate (250 mg)
 Other: Magnesium and/ or Potassium
Magnesium and/ or potassium supplements will be provided to patients of diabetes mellitus with insomnia
Experimental: Potassium group
Potassium group: Potassium chloride (250 mg)
 Other: Magnesium and/ or Potassium
Magnesium and/ or potassium supplements will be provided to patients of diabetes mellitus with insomnia
Experimental: Magnesium + Potassium group
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


Outcome Measures
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Primary Outcome Measures :
  1. Effects of magnesium and/ or potassium supplementation on insomnia severity patients with diabetes mellitus [ Time Frame: 60 days ]
    Insomnia Severity Index (ISI) will be used to assess and categorize the insomnia among patients with diabetes mellitus, before and after the intervention

  2. Effects of magnesium and/ or potassium on insulin resistance among insomnia patients with diabetes mellitus [ Time Frame: 60 days ]
    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.

  3. Effects of magnesium and/ or potassium on sleep hormones (melatonin, cortisol) among insomniac patients with diabetes mellitus. [ Time Frame: 60 days ]
    Sleep hormones (melatonin, cortisol) will be measured before and after the intervention, through ELISA technique, among insomniac patients with diabetes mellitus.

  4. Effect of magnesium and/ or potassium on serum electrolytes (Mg, K) among insomnia patients with diabetes mellitus [ Time Frame: 60 days ]
    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


Secondary Outcome Measures :
  1. Effect of magnesium and/ or potassium on quality of life (QOL) among insomnia patients with diabetes mellitus [ Time Frame: 60 days ]
    WHOQOL-BREF will be used to measure quality of life before and after the Mg, K supplementation, among insomniac patients with diabetes mellitus.

  2. Gender and age based response to magnesium and/ or potassium on insomnia patients with diabetes mellitus [ Time Frame: 60 days ]
    Gender and age based responses of Mg, K supplementation will be compared among insomniac patients with diabetes mellitus


Other Outcome Measures:
  1. Effect of magnesium and/ or potassium on quality liver function tests (LFTs) among insomnia patients with diabetes mellitus [ Time Frame: 60 Days ]
    Liver function tests (ALT, AST) will measured before and after the Mg, K supplementation among insomniac patients with diabetes mellitus


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04642313


Contacts
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Contact: Sidra Khalid 0923347498338 sidrakhalid.uaf@gmail.com
Contact: Shahid Bashir, PhD 092423200865 ext 5967 shahid.bashir@rsmi.uol.edu.pk

Locations
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Pakistan
Akhuwat Health Services Recruiting
Lahore, Punjab, Pakistan, 54000
Contact: Waseem Abbas, FCPS    0923314527672    wasimhashmi14@gmail.com   
The University of Lahore Recruiting
Lahore, Punjab, Pakistan, 54000
Contact: Shahid Bashir, PhD    0924232300865 ext 5967    shahid.bashir@rsmi.uol.edu.pk   
Sponsors and Collaborators
University of Lahore
More Information
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Responsible Party: Sidra Khalid, PhD Scholar, University of Lahore
ClinicalTrials.gov Identifier: NCT04642313    
Other Study ID Numbers: UOL-UIDNS-Mg-K
First Posted: November 24, 2020    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Patients data will be kept confidential and their identity will not be revealed

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sidra Khalid, University of Lahore:
Insomnia, Diabetes Mellitus, Magnesium, Potassium, Melatonin, Cortisol, Insulin resistance, Quality of Life
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Wake Disorders
Nervous System Diseases
Mental Disorders