Diabetes Mellitus, Type 2, Insulin Resistance
Conditions
Keywords
Type 2, Diabetes mellitus, Insulin
Brief summary
The goal of this \[Efficacy of a traditional anti-diabetic herbal drug with on glycemic, inflammatory, and oxidative stress parameters\] is \[investigate the level of HOMA-estimated insulin resistance as the primary outcome before and after 40 days in intervention and placebo groups\] in \[patients with type 2 diabetes\]. The secondary outcomes of this study are the assessment of oxidative stress, inflammation biomarkers, other glycemic indices, hematopoietic status and lipid profile between the two groups before and after the intervention. also The food frequency questionnaire (FFQ) and the physical activity questionnaire (FAQ) are used to evaluate the effect of potential confounding factors. This study has the code of ethics IR.KMU.REC.1402.291 from Kerman University of Medical Sciences and this drug has the number 12/14484 from Iran Food and Drug Administration (IFDA).
Detailed description
All the volunteers (Diabetic men and women with HbA1c more than 6.5 from the age of 20 to 65 years who usually use their standard medicine) who meet the entry criteria were directed to the laboratory and imaging center so that biochemical tests can be performed on them before taking the drug. Volunteers are asked to take the received medicine three times a day after food. It is worth mentioning that the patients will be divided into two groups by a person outside the research team, one group will drink herbal syrup and the other group will receive a placebo. A placebo with the same appearance as herbal syrup will drink nectar. On a weekly basis, the researcher will make phone calls with the applicants and, while reminding and recording the amount of herbal syrup consumed by drinking nectar, will also ask about the possible side effects of consuming herbal syrup drinking nectar. Then, at the end of the six week, the patient was asked to visit the clinic for a final evaluation. In this stage, the patient is asked about possible side effects, and the last stage of sample collection will be done to review all the tests of the next stage of receiving the drug (biochemical tests). Return at the end of week 6. The sample size in this study is 70 people.
Interventions
DRUGanti-diabetic herbal drug
All the volunteers directed to the laboratory so that biochemical tests can be performed on them before taking the drug. Volunteers are asked to take the received NOSHIN SHAHD drug 20 ml three times per day after food. at the end of the six week. then, the sample collection will be done to review all the tests of the end stage of receiving the drug.
Sponsors
Kerman Medical University
Afzalipour Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Anti-diabetic herbal and placebo syrups with the same color, shape, and box but different codes in two groups A and B are employed. After enrollment, each patient is allocated a code. Patients, researchers, and physicians who collect information in this study, assess outcomes, and analyze data for the study are blinded to the assigned treatment (anti-diabetic herbal or placebo) so that all patients are evaluated using their specific assigned code and treatment groups A or B.
Intervention model description
All the volunteers who meet the entry criteria were directed to the laboratory so that biochemical tests can be performed on them before taking the drug. Volunteers are asked to take the received medicine three times a day after food. they will be divided into two groups by a person outside the research team, one group will drink herbal syrup and the other group will receive a placebo. A placebo with the same appearance as herbal syrup will drink nectar. On a weekly basis, the researcher will make phone calls with the applicants and, while reminding and recording the amount of herbal syrup consumed by drinking nectar, will also ask about the possible side effects of consuming herbal syrup drinking nectar. Then, at the end of the six week, the patient was asked to visit the clinic for a final evaluation.
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age between 20 and 65 years 2. HbA1c more than 6.5 3. Consistency of diet and exercise program 4. Body mass index less than 35 5. Not receiving insulin 6. The patient should take standard medicine except insulin
Exclusion criteria
1. Performing CABG surgery, occurrence of ASC, heart and brain stroke, pulmonary embolism, deep vein thrombosis or TIA in the last 1 year. 2. Taking anti-inflammatory drugs such as aspirin with an anti-inflammatory dose, antioxidant supplements, vitamins and omega-3 capsules (\<1 g/day), and immunosuppressive drugs in the last three months. 3. Presence of cancer, liver and thyroid diseases. 4. pregnancy 5. Smoking and alcohol consumption
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HOMA-estimated insulin resistance | 40 days | To investigate the effect of the anti-diabetic herbal drug on changes in HOMA-IR in patients with T2DM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| plasma MDA | 40 days | Investigating the changes in plasma Malondialdehyde level as an oxidative stress factor |
| plasma protein carbonyl | 40 days | Investigating the changes in plasma protein carbonyl level as an oxidative stress factor |
| plasma TAC | 40 days | Investigating the changes in plasma total antioxidant capacity as an oxidative stress factor |
| plasma SOD enzyme activity | 40 days | Investigating the changes in plasma SOD enzyme activity as an oxidative stress factor |
| plasma catalase enzyme activity | 40 days | Investigating the changes in plasma catalase enzyme activity as an oxidative stress factor |
| plasma reduced glutathione | 40 days | Investigating the changes in plasma reduced glutathione levels as an oxidative stress factor |
| ROS in PBMCs | 40 days | Investigating the changes in ROS level in PBMCs as an oxidative stress factor |
| FBS | 40 days | Investigating the changes in fasting blood glucose as a glycemic status |
| fasting blood Insulin | 40 days | Investigating the changes in fasting blood Insulin as a glycemic status |
| HbA1c | 40 days | Investigating the changes in HbA1c level as a glycemic status |
| Inflammatory biomarkers | 40 days | Investigating the changes in plasma TNF-α, IL-6, IL-1β, and hs-CRP levels |
Countries
Iran
Outcome results
None listed