Trial · NCT05369793
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in fasting blood glucose | baseline and 3 months later | Using glucose oxidase method for assessment of blood glucose and subtracting pre-treatment from post-treatment values |
| Primary | Change in plasma insulin level | baseline and 3 months later | Subtracting pre-treatment from post-treatment values of plasma insulin |
| Primary | Change in HOMA-IR index | baseline and 3 months later | HOMA-IR will be calculated for all patients at baseline and 3 months later. |
| Primary | Change in HOMA-B index | baseline and 3 months later. | HOMA-B will be calculated for all patients at baseline and 3 months later. |
| Primary | Change in HbA1c | baseline and 3 months later | Subtracting pre-treatment from post-treatment values of HbA1C |
| Secondary | Changes in TNF-alfa serum level | baseline and 3 months later | Subtracting pre-treatment from post-treatment values of TNF-alfa. |
| Secondary | Changes in malondialdehyde serum level (MDA) | baseline and 3 months later | Subtracting pre-treatment from post-treatment values of MDA. |
| Secondary | Changes in neurotensin serum levels | baseline and 3 months later | Subtracting pre-treatment from post-treatment values of neurotensin serum levels. |
| Secondary | Ewing score | baseline and 3 months later | Subtracting pre-treatment from post-treatment changes in summation of the cardiac autonomic reflex tests (CARTs) including heart response to a deep breathing test, changes in immediate heart rate response to standing, and changes in blood pressure response to sustained handgrip testing. |
| Secondary | Changes of Michigan Neuropathy Screening Instrument | baseline and 3 months later | A 15-item questionnaire (MNSIQ) is used to assess deformation, infection, skin thickening of the skin's stratum corneum, and ulcers. MNSIQ was designed to screen for diabetic neuropathy through questionnaires on 15 questions that are related to neuropathic symptoms (pain, temperature, and sensation). Two of 15 (number 4 and 10) are vascular symptoms and are excluded from the total score regardless of the results. If you answered 'No' to questions 7 and 13, you will get 1 point. In the end, scores ranging from 0 to 13 indicate that the higher the score, the more severe the neuropathic symptoms. |
| Secondary | Changes of Michigan Neuropathy Screening Instrument(MNSIE) | baseline and 3 months later | A foot test (MNSIE) is used to assess deformation, infection, skin thickening of the skin's stratum corneum, and ulcers. MNSIE evaluates foot shape, foot ulceration, ankle reflex, sense of vibration of big toe, monofilament right and left. The score ranges from point 0 to 10, and when the score is above 2, it is diagnosed as neuropathy. |
| Secondary | Changes of Douleur Neuropathique-4 (DN4) questionnaire (DN4) | baseline and 3 months later | DN4 Neuropathic Pain Diagnostic Questionnaire which reflect positive symptoms for pain ( burning, painful cold, electric shocks, ) |
| Other | Assessment of changes in patients' quality of life | baseline and 3 months later | Using Diabetes Quality Of Life questionnaire (DQOL) |
| Other | Major adverse cardiovascular events (MACE) | 3 months | Major adverse cardiovascular events (MACE) as non-fatal myocardial infarction (MI), non-fatal stroke, and cardiovascular death. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT05369793/registered