Diabetes Mellitus, Type 2NCT05918068
Pyridoxine Effect on the Blood Glucose Level in Type 2 Diabetic Patients
A study testing Metformin 500 mg/day, Metformin 500 mg/day plus vitamin B6 300 mg/day and non-pharmacological therapy in people with Diabetes Mellitus, Type 2, run by Al-Rasheed University College at 1 site in Iraq.
Trial summary
Pyridoxal-5-phosphate (P.L.P.), the biologically active form of vitamin B6, is a coenzyme in 150 enzymatic reactions, including amino acid, carbohydrate, and lipid metabolism. Neurotransmitter production and breakdown depend on it. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Metformin 500 mg/day, Metformin 500 mg/day plus vitamin B6 300 mg/day and non-pharmacological therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteIraq
- Study dates
- 1 Nov 2022to 1 Apr 2023
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes mellitus newly diagnosed patient with age (Above 30) years.
- HbA1c less than or equal to 7.5%.
Who cannot join
- Type 1 Diabetes mellitus.
- Concomitant chronic diseases (Rheumatoid arthritis, anemia, asthma, endocrine disorders, renal failure, alcoholics, and patient on anti-T.B. or anti-epileptics).
- Females should be neither pregnant nor on oral contraceptive drugs.
- Not taking any vitamin or mineral supplementation.
- Should have no history of recent acute infection (within the previous two weeks).
Trial locations and contacts
1 site in 1 country.
Iraq1 site
Maysan Centre for Diabetes and Endocrinology
Maysan Governorate, 383421
About this study
Official title: Evaluation of the Role of Pyridoxine Adjuvant Therapy on the Blood Glucose Level in Type 2 Diabetic Patients
Pyridoxal-5-phosphate (P.L.P.), the biologically active form of vitamin B6, is a coenzyme in 150 enzymatic reactions, including amino acid, carbohydrate, and lipid metabolism. Neurotransmitter production and breakdown depend on it. Additionally, it functions as an antioxidant by suppressing reactive oxygen species and mitigating the development of advanced glycation end products. Humans recycle P.L.P. from dietary B6 vitamins, and this molecule has been related to various clinically relevant diseases. Pyridoxine as an additional therapy for type 2 diabetes will be examined in this study.
Read the detailed description
Numerous organs might suffer long-term harm, malfunction, and failure as a result of type 2 diabetes. While the illness may initially cause weight loss, frequent urination, thirst, and hazy vision, the long-term repercussions may include the gradual onset of specific issues such as cardiovascular disease (CVD), retinopathy, which may culminate in blindness, and renal disease. The risk of foot ulcers, Charcot joints, and symptoms of autonomic dysfunction, such as sexual dysfunction, is associated with renal failure and/or neuropathy. Diabetes and vitamin B6 have both been linked. It is not apparent, therefore, whether diabetes is a consequence of low P.L.P. levels, a cause, or both. According to some study, diabetes may develop as a consequence of low P.L.P. levels, however other studies suggest that diabetes decreases P.L.P. levels. Although the physiological and molecular pathways behind these beneficial effects on diabetic pathology and related repercussions are not completely understood, multiple investigations have demonstrated that B6 therapy has good effects. There are numerous ways that pyridoxal 5-phosphate deficiency affects diabetes. As an essential element for numerous enzymes that contribute to this process, pyridoxal-5-phosphate can, for example, influence the route that converts tryptophan into niacin. It has been proven that the metabolites produced when this pathway is damaged lessen the bioactivity of insulin and cause insulin resistance, a T2D symptom . Pyridoxal-5-phosphate may influence insulin resistance via modulating the expression of adipogenesis-related genes. The degradation of co-enzyme-dependent enzymes like (C.B.S.) and (C.G.L.), which rely on pyridoxal-5-phosphate, may also promote insulin resistance via elevating homocysteine levels .
This research intends to examine the impact of pyridoxine adjuvant treatment on the blood glucose level in type 2 diabetes patients.
This is a randomized controlled open-label interventional study. T2DM patients who receive either (metformin with pyridoxine) or (metformin only) daily and T2DM patients treated with non-pharmacological therapy (lifestyle modification) will be included in the study.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Metformin 500 mg/day, Metformin 500 mg/day plus vitamin B6 300 mg/day, non-pharmacological therapy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin 500 mg/dayDrug
Also called Metformin group
Metformin 500 mg/day in addition to non-pharmacological therapy
Metformin 500 mg/day plus vitamin B6 300 mg/dayCombination product
Also called Combination group
Metformin 500 mg/day plus vitamin B6 300 mg/day in addition to non-pharmacological therapy
non-pharmacological therapyOther
Also called control group
non-pharmacological therapy (healthy lifestyle modifications)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Newly diagnosed patients with T2DM, treated with non-pharmacological therapy (lifestyle modification). Receives: Other: non-pharmacological therapy |
| Metformin only group | Active comparator | T2DM patients treated with metformin 500 mg/day in addition to non-pharmacological therapy (lifestyle modification) Receives: Drug: Metformin 500 mg/day; Other: non-pharmacological therapy |
| Combination group | Experimental | T2DM patients treated with metformin 500 mg/day plus vitamin B6 300 mg/day in addition to non-pharmacological therapy (lifestyle modification) Receives: Drug: Metformin 500 mg/day; Combination Product: Metformin 500 mg/day plus vitamin B6 300 mg/day; Other: non-pharmacological therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting plasma glucose (FPG).
A fasting plasma glucose test, also known as a fasting glucose test (FGT), is a test that can be used to help diagnose diabetes or pre-diabetes.The expected values for normal fasting blood glucose concentration are between 70 mg/dL (3.9 mmol/L) and 100 mg/dL (5.6 mmol/L). When fasting blood glucose is between 100 to 125 mg/dL (5.6 to 6.9 mmol/L), changes in lifestyle and monitoring glycemia are recommended
Measured: Change from baseline, to one month
Glycated Hemoglobin (HbAlc)
A normal A1C level is below 5.7%, a level of 5.7% to 6.4% indicates prediabetes and a level of 6.5% or more indicates diabetes.
Measured: Change from baseline, to one month
Secondary outcomes (4)
Vitamin B6
The reference range for pyridoxal phosphate (PLP), the biologically active form of vitamin B6, is 5-50 µg/L.
Measured: Change from baseline, to one month
Fasting plasma insulin (F.P.I.).
The insulin fasting blood test is chiefly used to test insulin levels and diagnose diabetes and insulin resistance.
Measured: Change from baseline, to one month
Insulin resistance (HOMA-IR).
Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance. Above 2.9 indicates significant insulin resistance.
Measured: Change from baseline, to one month
Indoleamine 2,3 dioxygenase (IDO)
Has the potential role of indoleamine 2,3 dioxygenase (IDO) as a predictive and therapeutic target for diabetes treatment
Measured: Change from baseline, to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start1 Nov 2022
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Rasheed University College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918068
- Sponsor's protocol ID
- AR200108
- Status last verified
- May 2023
- First submitted
- 30 May 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mascolo E, Verni F. Vitamin B6 and Diabetes: Relationship and Molecular Mechanisms. Int J Mol Sci. 2020 May 23;21(10):3669. doi: 10.3390/ijms21103669.
PubMed 32456137Merigliano C, Mascolo E, Burla R, Saggio I, Verni F. The Relationship Between Vitamin B6, Diabetes and Cancer. Front Genet. 2018 Sep 13;9:388. doi: 10.3389/fgene.2018.00388. eCollection 2018.
PubMed 30271425Petersmann A, Muller-Wieland D, Muller UA, Landgraf R, Nauck M, Freckmann G, Heinemann L, Schleicher E. Definition, Classification and Diagnosis of Diabetes Mellitus. Exp Clin Endocrinol Diabetes. 2019 Dec;127(S 01):S1-S7. doi: 10.1055/a-1018-9078. Epub 2019 Dec 20. No abstract available.
PubMed 31860923
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Pyridoxine Adjuvant Therapy on the Blood Glucose Level in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT05918068
- Acronym / sponsor ID
- AR200108
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Al-Rasheed University CollegeUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 26 Jun 2023 (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.
Pyridoxal-5-phosphate (P.L.P.), the biologically active form of vitamin B6, is a coenzyme in 150 enzymatic reactions, including amino acid, carbohydrate, and lipid metabolism. Neurotransmitter production and breakdown depend on it. Additionally, it functions as an antioxidant by suppressing reactive oxygen species and mitigating the development of advanced glycation end products. Humans recycle P.L.P. from dietary B6 vitamins, and this molecule has been related to various clinically relevant diseases. Pyridoxine as an additional therapy for type 2 diabetes will be examined in this study.
Detailed description
Numerous organs might suffer long-term harm, malfunction, and failure as a result of type 2 diabetes. While the illness may initially cause weight loss, frequent urination, thirst, and hazy vision, the long-term repercussions may include the gradual onset of specific issues such as cardiovascular disease (CVD), retinopathy, which may culminate in blindness, and renal disease. The risk of foot ulcers, Charcot joints, and symptoms of autonomic dysfunction, such as sexual dysfunction, is associated with renal failure and/or neuropathy. Diabetes and vitamin B6 have both been linked. It is not apparent, therefore, whether diabetes is a consequence of low P.L.P. levels, a cause, or both. According to some study, diabetes may develop as a consequence of low P.L.P. levels, however other studies suggest that diabetes decreases P.L.P. levels. Although the physiological and molecular pathways behind these beneficial effects on diabetic pathology and related repercussions are not completely understood, multiple investigations have demonstrated that B6 therapy has good effects. There are numerous ways that pyridoxal 5-phosphate deficiency affects diabetes. As an essential element for numerous enzymes that contribute to this process, pyridoxal-5-phosphate can, for example, influence the route that converts tryptophan into niacin. It has been proven that the metabolites produced when this pathway is damaged lessen the bioactivity of insulin and cause insulin resistance, a T2D symptom . Pyridoxal-5-phosphate may influence insulin resistance via modulating the expression of adipogenesis-related genes. The degradation of co-enzyme-dependent enzymes like (C.B.S.) and (C.G.L.), which rely on pyridoxal-5-phosphate, may also promote insulin resistance via elevating homocysteine levels .
This research intends to examine the impact of pyridoxine adjuvant treatment on the blood glucose level in type 2 diabetes patients.
This is a randomized controlled open-label interventional study. T2DM patients who receive either (metformin with pyridoxine) or (metformin only) daily and T2DM patients treated with non-pharmacological therapy (lifestyle modification) will be included in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: non-pharmacological therapyNewly diagnosed patients with T2DM, treated with non-pharmacological therapy (lifestyle modification). |
| Metformin only group | Active comparator | Drug: Metformin 500 mg/day, Other: non-pharmacological therapyT2DM patients treated with metformin 500 mg/day in addition to non-pharmacological therapy (lifestyle modification) |
| Combination group | Experimental | Drug: Metformin 500 mg/day, Combination Product: Metformin 500 mg/day plus vitamin B6 300 mg/day, Other: non-pharmacological therapyT2DM patients treated with metformin 500 mg/day plus vitamin B6 300 mg/day in addition to non-pharmacological therapy (lifestyle modification) |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 Diabetes mellitus newly diagnosed patient with age (Above 30) years.
- HbA1c less than or equal to 7.5%.
Key exclusion criteria (5 listed)
- Type 1 Diabetes mellitus.
- Concomitant chronic diseases (Rheumatoid arthritis, anemia, asthma, endocrine disorders, renal failure, alcoholics, and patient on anti-T.B. or anti-epileptics).
- Females should be neither pregnant nor on oral contraceptive drugs.
- Not taking any vitamin or mineral supplementation.
- Should have no history of recent acute infection (within the previous two weeks).
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 |
|---|---|---|
| Metformin 500 mg/dayAlso: Metformin groupMetformin 500 mg/day in addition to non-pharmacological therapy | Drug | Combination group, Metformin only group |
| Metformin 500 mg/day plus vitamin B6 300 mg/dayAlso: Combination groupMetformin 500 mg/day plus vitamin B6 300 mg/day in addition to non-pharmacological therapy | Combination product | Combination group |
| non-pharmacological therapyAlso: control groupnon-pharmacological therapy (healthy lifestyle modifications) | Other | Combination group, Control group, Metformin only group |
Primary outcome
Fasting plasma glucose (FPG).
Time frame: Change from baseline, to one month
A fasting plasma glucose test, also known as a fasting glucose test (FGT), is a test that can be used to help diagnose diabetes or pre-diabetes.The expected values for normal fasting blood glucose concentration are between 70 mg/dL (3.9 mmol/L) and 100 mg/dL (5.6 mmol/L). When fasting blood glucose is between 100 to 125 mg/dL (5.6 to 6.9 mmol/L), changes in lifestyle and monitoring glycemia are recommended
Glycated Hemoglobin (HbAlc)
Time frame: Change from baseline, to one month
A normal A1C level is below 5.7%, a level of 5.7% to 6.4% indicates prediabetes and a level of 6.5% or more indicates diabetes.
4 secondary outcomes
Vitamin B6
Time frame: Change from baseline, to one month
Fasting plasma insulin (F.P.I.).
Time frame: Change from baseline, to one month
Insulin resistance (HOMA-IR).
Time frame: Change from baseline, to one month
Indoleamine 2,3 dioxygenase (IDO)
Time frame: Change from baseline, to one month
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 26 Jun 2023.
- Background: PubMed 32456137Mascolo E, Verni F. Vitamin B6 and Diabetes: Relationship and Molecular Mechanisms. Int J Mol Sci. 2020 May 23;21(10):3669. doi: 10.3390/ijms21103669.
- Background: PubMed 30271425Merigliano C, Mascolo E, Burla R, Saggio I, Verni F. The Relationship Between Vitamin B6, Diabetes and Cancer. Front Genet. 2018 Sep 13;9:388. doi: 10.3389/fgene.2018.00388. eCollection 2018.
- Background: PubMed 31860923Petersmann A, Muller-Wieland D, Muller UA, Landgraf R, Nauck M, Freckmann G, Heinemann L, Schleicher E. Definition, Classification and Diagnosis of Diabetes Mellitus. Exp Clin Endocrinol Diabetes. 2019 Dec;127(S 01):S1-S7. doi: 10.1055/a-1018-9078. Epub 2019 Dec 20. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin 500 mg/day, Metformin 500 mg/day plus vitamin B6 300 mg/day and non-pharmacological therapy in people with Diabetes Mellitus, Type 2, run by Al-Rasheed University College 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 2 inclusion and 5 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 26 Jun 2023. 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?
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?
Fasting plasma glucose (FPG). (time frame: Change from baseline, to one month). The study lists 2 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 NCT05918068, which also lists 3 linked publications.
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 26 Jun 2023; AzTrials last refreshed its copy on 6 Nov 2026.