Focus of Study is on Insomnia Among Diabetic PatientsNCT04642313
Comparison of Mg Vs. K Supplementation on Insomnia in Diabetics
A study testing Magnesium and/ or Potassium in people with Focus of Study is on Insomnia Among Diabetic Patients, run by University of Lahore at 2 sites in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Focus of Study is on Insomnia Among Diabetic Patients
- What is being tested?
- Magnesium and/ or Potassium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 2 sitesPakistan
- Study dates
- 26 Oct 2020to 26 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- 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)
Show all 19Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites, 2 recruiting
- Recruiting
Akhuwat Health Services
Lahore, Punjab Province, 54000
Waseem Abbas, FCPS, 0923314527672, wasimhashmi14@gmail.com
- Recruiting
The University of Lahore
Lahore, Punjab Province, 54000
Shahid Bashir, PhD, 0924232300865 ext. 5967, shahid.bashir@rsmi.uol.edu.pk
About this study
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".
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.
Read the 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:
- 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
- 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
- Being tested
- Magnesium and/ or Potassium
- Keywords
- Insomnia, Diabetes Mellitus, Magnesium, Potassium, Melatonin, Cortisol, Insulin resistance, Quality of Life
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium and/ or PotassiumOther
Magnesium and/ or potassium supplements will be provided to patients of diabetes mellitus with insomnia
| Study group | Role | What they receive |
|---|---|---|
| PLACEBO group | Placebo comparator | Placebo treatment: starch tablets (250 mg) Receives: Other: Magnesium and/ or Potassium |
| Magnesium group | Experimental | Magnesium group: Magnesium gluconate (250 mg) Receives: Other: Magnesium and/ or Potassium |
| Potassium group | Experimental | Potassium group: Potassium chloride (250 mg) Receives: Other: Magnesium and/ or Potassium |
| Magnesium + Potassium group | Experimental | Magnesium + Potassium group: Magnesium gluconate (250 mg) + Potassium chloride (250 mg) Receives: Other: Magnesium and/ or Potassium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 60 days
Secondary outcomes (2)
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.
Measured: 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
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start26 Oct 2020
- Primary completion26 Apr 2021 (estimated)
- Study completion26 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Focus of Study is on Insomnia Among Diabetic PatientsStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be divided into 4 groups and will receive 4 different treatments at same time
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sidra Khalid, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642313
- Sponsor's protocol ID
- UOL-UIDNS-Mg-K
- Status last verified
- Nov 2020
- First submitted
- 9 Nov 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patients data will be kept confidential and their identity will not be revealed
Publications
Khalid S, Mehboob R, Bokhari SS, Ali M, Shabbir A, Mehboob K, Adnan H, Karami MM, Shalabi H, Alshehri B. Comparative Efficacy of Magnesium and Potassium Towards Cholesterol and Quality of Life in Patients With Type 2 Diabetes Mellitus: A Randomised Single-Blinded Controlled Clinical Trial. Endocrinol Diabetes Metab. 2024 Nov;7(6):e511. doi: 10.1002/edm2.511.
PubMed 39410716
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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".
- ClinicalTrials.gov ID
- NCT04642313
- Acronym / sponsor ID
- UOL-UIDNS-Mg-K
- Keywords
- Insomnia, Diabetes Mellitus, Magnesium, Potassium, Melatonin, Cortisol, Insulin resistance, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 26 Apr 2021 (estimated)
- Study completion
- 26 Apr 2022 (estimated)
- First posted
- 24 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Participants will be divided into 4 groups and will receive 4 different treatments at same time
| Arm | Type | Receives |
|---|---|---|
| PLACEBO group | Placebo comparator | Other: Magnesium and/ or PotassiumPlacebo treatment: starch tablets (250 mg) |
| Magnesium group | Experimental | Other: Magnesium and/ or PotassiumMagnesium group: Magnesium gluconate (250 mg) |
| Potassium group | Experimental | Other: Magnesium and/ or PotassiumPotassium group: Potassium chloride (250 mg) |
| Magnesium + Potassium group | Experimental | Other: Magnesium and/ or PotassiumMagnesium + Potassium group: Magnesium gluconate (250 mg) + Potassium chloride (250 mg) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • Patients of diabetes mellitus with insomnia
Key exclusion criteria (19 listed)
- Individuals with the following conditions will not be included as participants, patients of diabetes mellitus with insomnia with
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium and/ or PotassiumMagnesium and/ or potassium supplements will be provided to patients of diabetes mellitus with insomnia | Other | Magnesium + Potassium group, Magnesium group, PLACEBO group, Potassium group |
Primary outcome
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
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.
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.
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
2 secondary outcomes
Effect of magnesium and/ or potassium on quality of life (QOL) among insomnia patients with diabetes mellitus
Time frame: 60 days
Gender and age based response to magnesium and/ or potassium on insomnia patients with diabetes mellitus
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Derived from this study: PubMed 39410716Khalid S, Mehboob R, Bokhari SS, Ali M, Shabbir A, Mehboob K, Adnan H, Karami MM, Shalabi H, Alshehri B. Comparative Efficacy of Magnesium and Potassium Towards Cholesterol and Quality of Life in Patients With Type 2 Diabetes Mellitus: A Randomised Single-Blinded Controlled Clinical Trial. Endocrinol Diabetes Metab. 2024 Nov;7(6):e511. doi: 10.1002/edm2.511.
- Individual participant dataSharing planned: No. Patients data will be kept confidential and their identity will not be revealed
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium and/ or Potassium in people with Focus of Study is on Insomnia Among Diabetic Patients, run by University of Lahore at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sidra Khalid (0923347498338, sidrakhalid.uaf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of magnesium and/ or potassium supplementation on insomnia severity patients with diabetes mellitus (time frame: 60 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04642313, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.