Comparison of Mg Vs. K Supplementation on Insomnia in Diabetics

November 17, 2020 updated by: Sidra Khalid, University of Lahore

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
      • Lahore, Punjab, Pakistan, 54000
        • Recruiting
        • Akhuwat Health Services
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
60 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2020

Primary Completion (Anticipated)

April 26, 2021

Study Completion (Anticipated)

April 26, 2022

Study Registration Dates

First Submitted

November 9, 2020

First Submitted That Met QC Criteria

November 17, 2020

First Posted (Actual)

November 24, 2020

Study Record Updates

Last Update Posted (Actual)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 17, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UOL-UIDNS-Mg-K

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Patients data will be kept confidential and their identity will not be revealed

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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