Diabetic Peripheral NeuropathyNCT03356041
The Role of a Clinical Pharmacist in Lifestyle Modification in Type 2 Diabetic Patients With Peripheral Neuropathy
A study testing Diabetic patients with neuropathy in people with Diabetic Peripheral Neuropathy, run by Hawler Medical University at 1 site in Iraq.
Trial summary
The aims of this study are to determine the prevalence of diabetic peripheral neuropathy among the diabetic patients, to determine the association between the clinical profiles of the diabetic patients (diabetes type, diabetes duration, HbA1c, body mass index, hypertension, total cholesterol) and the diabetic… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Diabetic patients with neuropathy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIraq
- Study dates
- 20 Dec 2017to 23 Mar 2018
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18 years or older.
- Both sex.
- Diagnosed with type 2 diabetes at least one year previously.
- Took at least one prescribed medication for diabetes.
- Diagnosed as diabetic peripheral neuropathy based on clinical
Who cannot join
- History of alcohol consumption.
- Thyroid gland disorder.
- Any kidney disorder.
- Any conditions that could confound assessment of pain due to diabetic peripheral neuropathy.
- Have foot injury or open sore.
- Pregnant females or who plan to become pregnant during the study period.
- Any serious medical condition that might prevent completion or hinder compliance with exercise.
- -
Trial locations and contacts
1 site in 1 country.
Iraq1 site, 1 recruiting
- Recruiting
Prof. Kawa Dizaye
Erbil
Kawa Dizaye, PhD, 009647504452392, kawa.dizaye@hmu.edu.iq
Anfal Al-Mallah, MSc, 009647702080031, anfalalmallah@gmail.com
About this study
Official title: The Role of a Clinical Pharmacist in Lifestyle Modification
The aims of this study are to determine the prevalence of diabetic peripheral neuropathy among the diabetic patients, to determine the association between the clinical profiles of the diabetic patients (diabetes type, diabetes duration, HbA1c, body mass index, hypertension, total cholesterol) and the diabetic peripheral neuropathy DPN and the rational poly pharmacy used to control pain.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Diabetic patients with neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetic patients with neuropathyOther
Also called Intervention group
Lifestyle modification will be assessed using summary of diabetes self-care activity
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | The intervention group will receive the three months' lifestyle modification program by a clinical pharmacist. Receives: Other: Diabetic patients with neuropathy |
| Usual care Group | No intervention | The usual care group will be provided the standard medical services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimating Summary of diabetes self-care activity (SDSCA)
Assessing Lifestyle modification by summary of diabetes self-care activity (SDSCA) at baseline visit and after three months for both Intervention patients and usual care group Increases in the means of the items of the scale as Exercise, Blood sugar testing, Specific diet and Foot care in the intervention group.
Measured: Three months
Adherence to treatment according to Morisky scale
Morisky scale is used to assess medication adherence at baseline visit and after three months for both Intervention patients and usual care group.
Improving the patient medication adherence behavior in the intervention group patients
Measured: Three months
Douleur Neuropathique 4 (DN4), Neuropathic Pain Scale (NPS),
Reduction in the percent of response of patients feeling; electric shock, tingling, and pin needle after the lifestyle modification in the intervention group.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start20 Dec 2017 (estimated)
- Primary completion16 Mar 2018 (estimated)
- Study completion23 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kawa Dizaye, Hawler Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356041
- Sponsor's protocol ID
- Hawler Med University
- Status last verified
- Nov 2017
- First submitted
- 17 Nov 2017
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of a Clinical Pharmacist in Lifestyle Modification
- ClinicalTrials.gov ID
- NCT03356041
- Acronym / sponsor ID
- Hawler Med University
- Conditions
- Diabetic Peripheral Neuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 20 Dec 2017 (estimated)
- Primary completion
- 16 Mar 2018 (estimated)
- Study completion
- 23 Mar 2018 (estimated)
- First posted
- 29 Nov 2017 (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.
The aims of this study are to determine the prevalence of diabetic peripheral neuropathy among the diabetic patients, to determine the association between the clinical profiles of the diabetic patients (diabetes type, diabetes duration, HbA1c, body mass index, hypertension, total cholesterol) and the diabetic peripheral neuropathy DPN and the rational poly pharmacy used to control pain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Other: Diabetic patients with neuropathyThe intervention group will receive the three months' lifestyle modification program by a clinical pharmacist. |
| Usual care Group | No intervention | –The usual care group will be provided the standard medical services |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18 years or older.
- Both sex.
- Diagnosed with type 2 diabetes at least one year previously.
- Took at least one prescribed medication for diabetes.
- Diagnosed as diabetic peripheral neuropathy based on clinical
Key exclusion criteria (8 listed)
- History of alcohol consumption.
- Thyroid gland disorder.
- Any kidney disorder.
- Any conditions that could confound assessment of pain due to diabetic peripheral neuropathy.
- Have foot injury or open sore.
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 |
|---|---|---|
| Diabetic patients with neuropathyAlso: Intervention groupLifestyle modification will be assessed using summary of diabetes self-care activity | Other | Intervention Group |
Primary outcome
Estimating Summary of diabetes self-care activity (SDSCA)
Time frame: Three months
Assessing Lifestyle modification by summary of diabetes self-care activity (SDSCA) at baseline visit and after three months for both Intervention patients and usual care group Increases in the means of the items of the scale as Exercise, Blood sugar testing, Specific diet and Foot care in the intervention group.
Adherence to treatment according to Morisky scale
Time frame: Three months
Morisky scale is used to assess medication adherence at baseline visit and after three months for both Intervention patients and usual care group. Improving the patient medication adherence behavior in the intervention group patients
Douleur Neuropathique 4 (DN4), Neuropathic Pain Scale (NPS),
Time frame: Three months
Reduction in the percent of response of patients feeling; electric shock, tingling, and pin needle after the lifestyle modification in the intervention group.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetic patients with neuropathy in people with Diabetic Peripheral Neuropathy, run by Hawler Medical University at 1 site in Iraq.
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 5 inclusion and 8 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 29 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimating Summary of diabetes self-care activity (SDSCA) (time frame: Three months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2017.