Diabetic PolyneuropathyNCT04322240
Alpha Lipoic Acid and Diabetes Mellitus: Potential Effects on Peripheral Neuropathy
A study testing Alpha lipoic acid in people with Diabetic Polyneuropathy and Diabetes Mellitus, Type 2, run by Benha University at 1 site in Egypt.
Trial summary
Patients with type 2 DM who are following will be enrolled into the study. Two visits were scheduled for data collection, physical examination and laboratory testing of the patients: the first prior to initiation of alpha lipoic acid (ALA) administration (baseline visit) and the second at the end of the third month… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Diabetic Polyneuropathy, Diabetes Mellitus, Type 2
- What is being tested?
- Alpha lipoic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Apr 2020to 23 Dec 2020
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient's agreement to participate
- Diabetic peripheral neuropathy
Who cannot join
- Causes of neuropathy other than diabetes
- Severe renal disease
- Recent treatment for cancer or haematological malignancies;
- Presence of foot ulcers;
- Peripheral arterial disease ;
- Use of agents in the previous 3 months that could interfere with the interpretation of results, such as opiates, vitamin B compounds or antioxidants;
- Pregnancy
- Lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alpha Lipoic Acid and Diabetes Mellitus: Potential Effects on Peripheral Neuropathy and Different Metabolic Parameters
Patients with type 2 DM who are following will be enrolled into the study. Two visits were scheduled for data collection, physical examination and laboratory testing of the patients: the first prior to initiation of alpha lipoic acid (ALA) administration (baseline visit) and the second at the end of the third month following initiation of ALA (2nd visit).
Read the detailed description
This prospective, Interventional study will be conducted at Benha university hospital for 3 months. Patients with type 2 DM who are following at the outpatient internal medicine \& diabetes Clinics in Benha Univeristy Hospital and are eligible to participate, will be enrolled into the study. Inclusion criteria comprise the following(1) patient's agreement to participate; (2) diabetic peripheral neuropathy diagnosis (3) treatment with alpha lipolic acid (ALA), had to be stable for 3 months during the study.
Two visits were scheduled for data collection, physical examination and laboratory testing of the patients: the first prior to initiation of ALA administration (baseline visit) and the second at the end of the third month following initiation of ALA (2nd visit).
evaluation include:
- full neurological evaluation including motor, sensory, ankle reflex, Tests for cardiac parasympathetic action
- nerve conduction study
- neuromuscular ultrasound
- HbA1C 5- HDL-C\& LDL-C
- Conditions
- Diabetic Polyneuropathy, Diabetes Mellitus, Type 2
- Being tested
- Alpha lipoic acid
- Medical subject headings
- Diabetic Neuropathies, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha lipoic acidDrug
Also called Thiotacid
Participants will be prescribed 600 mg/day ALA (thiotacid) orally, for 3 months, and will be advised not to discontinue this medication
| Study group | Role | What they receive |
|---|---|---|
| type 2 DM with peripheral neuropathy | Experimental | Participants will be prescribed 600 mg/day ALA (thiotacid) orally, for 3 months, and will be advised not to discontinue this medication, antidiabetic drugs, or medications used for managing arterial hypertension or dyslipidaemia during the study. Receives: Drug: Alpha lipoic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
monofilament test of both feet
5.07 (10 gram) monofilament will be used to test loss of protective sensation of at 10 sites in each feet at baseline and after use of alpha lipoic acid. the score range from 0 (worst) to 10 (best)
Measured: : through study completion, an average of 3months
Vibration Perception Threshold (VPT)
VPT was evaluated using a 128-Hz tuning fork applied bilaterally at the tip of the great toe. Responses were categorized as abnormal (no perception of vibration),present (examiner perceives vibration <10sec after patient reported disappearance of vibration perception) ,and reduced (examiner perceives vibration >10 seconds after patient reported disappearance of vibration perception).
Measured: : through study completion, an average of 3 months
neuromuscular ultrasound
the cross sectional area of the posterior tibial nerve will be assessed in both sides at baseline and after use of alpha lipoic acid
Measured: : through study completion, an average of 3 months
concentration of Hemoglobin A1c
the participants were divided into two categories that include good glycemic control (HA1c≤7%), poor glycemic control (≥ HA1c 7 %),
Measured: : through study completion, an average of 3 months
serum concentrations of high density lipoproteins-cholesterol (HDL-C)
A low HDL cholesterol level was defined as <1.03 mmol/l( 40 mg/dl) for men and <1.29mmol/L(50 mg/dl) for women
Measured: : through study completion, an average of 3 months
serum concentrations of low density lipoproteins-cholesterol (LDL-C)
a patient of LDL-C equal or more than 3.3mmol/L (129mg/dl) is defined as dyslipidemic.
Measured: : through study completion, an average of 3 months
ankle reflex
ranging from 0 (absent) to 4 (hyperactive with clonus)
Measured: : through study completion, an average of 3 months
Measurement of nerve conduction velocity
sensory and motor conduction velocity are measured in meter/second in common peroneal and posterior tibial nerves on both sides at baseline and after use of alpha lipoic acid
Measured: : through study completion, an average of 3 months
measurement of Compound Muscle Action Potential (CMAP) amplitudes
amplitude is measured in micro or millivolts in common peroneal and posterior tibial nerves on both sides at baseline and after use of alpha lipoic acid
Measured: : through study completion, an average of 3 months
measurement of Compound Muscle Action Potential (CMAP) distal latency
distal latency measured in milliseconds and evaluated in common peroneal and posterior tibial nerves on both sides at baseline and after use of alpha lipoic acid
Measured: : through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start2 Apr 2020
- Primary completion23 Oct 2020
- Study completion23 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic PolyneuropathyStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Ahmed Salaheldeen Hassan, Benha University
- Investigators
- Amira Mohamady, MD, Principal investigator, Benha university- Qaluibya- Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322240
- Sponsor's protocol ID
- Benha22020
- Status last verified
- Dec 2020
- First submitted
- 23 Mar 2020
- Last updated
- 30 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alpha Lipoic Acid and Diabetes Mellitus: Potential Effects on Peripheral Neuropathy and Different Metabolic Parameters
- ClinicalTrials.gov ID
- NCT04322240
- Acronym / sponsor ID
- Benha22020
- Conditions
- Diabetic Polyneuropathy, Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- 23 Oct 2020 (actual)
- Study completion
- 23 Dec 2020 (actual)
- First posted
- 26 Mar 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.
Patients with type 2 DM who are following will be enrolled into the study. Two visits were scheduled for data collection, physical examination and laboratory testing of the patients: the first prior to initiation of alpha lipoic acid (ALA) administration (baseline visit) and the second at the end of the third month following initiation of ALA (2nd visit).
Detailed description
This prospective, Interventional study will be conducted at Benha university hospital for 3 months. Patients with type 2 DM who are following at the outpatient internal medicine \& diabetes Clinics in Benha Univeristy Hospital and are eligible to participate, will be enrolled into the study. Inclusion criteria comprise the following(1) patient's agreement to participate; (2) diabetic peripheral neuropathy diagnosis (3) treatment with alpha lipolic acid (ALA), had to be stable for 3 months during the study.
Two visits were scheduled for data collection, physical examination and laboratory testing of the patients: the first prior to initiation of ALA administration (baseline visit) and the second at the end of the third month following initiation of ALA (2nd visit).
evaluation include:
- full neurological evaluation including motor, sensory, ankle reflex, Tests for cardiac parasympathetic action
- nerve conduction study
- neuromuscular ultrasound
- HbA1C 5- HDL-C\& LDL-C
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| type 2 DM with peripheral neuropathy | Experimental | Drug: Alpha lipoic acidParticipants will be prescribed 600 mg/day ALA (thiotacid) orally, for 3 months, and will be advised not to discontinue this medication, antidiabetic drugs, or medications used for managing arterial hypertension or dyslipidaemia during the study. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patient's agreement to participate
- Diabetic peripheral neuropathy
Key exclusion criteria (8 listed)
- Causes of neuropathy other than diabetes
- Severe renal disease
- Recent treatment for cancer or haematological malignancies;
- Presence of foot ulcers;
- Peripheral arterial disease ;
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 |
|---|---|---|
| Alpha lipoic acidAlso: ThiotacidParticipants will be prescribed 600 mg/day ALA (thiotacid) orally, for 3 months, and will be advised not to discontinue this medication | Drug | type 2 DM with peripheral neuropathy |
Primary outcome
monofilament test of both feet
Time frame: : through study completion, an average of 3months
5.07 (10 gram) monofilament will be used to test loss of protective sensation of at 10 sites in each feet at baseline and after use of alpha lipoic acid. the score range from 0 (worst) to 10 (best)
Vibration Perception Threshold (VPT)
Time frame: : through study completion, an average of 3 months
VPT was evaluated using a 128-Hz tuning fork applied bilaterally at the tip of the great toe. Responses were categorized as abnormal (no perception of vibration),present (examiner perceives vibration <10sec after patient reported disappearance of vibration perception) ,and reduced (examiner perceives vibration >10 seconds after patient reported disappearance of vibration perception).
neuromuscular ultrasound
Time frame: : through study completion, an average of 3 months
the cross sectional area of the posterior tibial nerve will be assessed in both sides at baseline and after use of alpha lipoic acid
concentration of Hemoglobin A1c
Time frame: : through study completion, an average of 3 months
the participants were divided into two categories that include good glycemic control (HA1c≤7%), poor glycemic control (≥ HA1c 7 %),
serum concentrations of high density lipoproteins-cholesterol (HDL-C)
Time frame: : through study completion, an average of 3 months
A low HDL cholesterol level was defined as <1.03 mmol/l( 40 mg/dl) for men and <1.29mmol/L(50 mg/dl) for women
serum concentrations of low density lipoproteins-cholesterol (LDL-C)
Time frame: : through study completion, an average of 3 months
a patient of LDL-C equal or more than 3.3mmol/L (129mg/dl) is defined as dyslipidemic.
ankle reflex
Time frame: : through study completion, an average of 3 months
ranging from 0 (absent) to 4 (hyperactive with clonus)
Measurement of nerve conduction velocity
Time frame: : through study completion, an average of 3 months
sensory and motor conduction velocity are measured in meter/second in common peroneal and posterior tibial nerves on both sides at baseline and after use of alpha lipoic acid
measurement of Compound Muscle Action Potential (CMAP) amplitudes
Time frame: : through study completion, an average of 3 months
amplitude is measured in micro or millivolts in common peroneal and posterior tibial nerves on both sides at baseline and after use of alpha lipoic acid
measurement of Compound Muscle Action Potential (CMAP) distal latency
Time frame: : through study completion, an average of 3 months
distal latency measured in milliseconds and evaluated in common peroneal and posterior tibial nerves on both sides at baseline and after use of alpha lipoic acid
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Amira Mohamady, MD principal investigator
Benha university- Qaluibya- Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpha lipoic acid in people with Diabetic Polyneuropathy and Diabetes Mellitus, Type 2, run by Benha University at 1 site in Egypt.
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 2 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: finished, as of the sponsor's last update on 30 Dec 2020. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
monofilament test of both feet (time frame: : through study completion, an average of 3months). The study lists 10 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 30 Dec 2020.