Type 2 Diabetes
Conditions
Keywords
Type 2 diabetes, Insulin resistance, Lipochromin, Vaccinium macrocarpon, Medicago sativa, Trigonella, Fenugreek, Lemon Beebrush, Urtica dioica, Rhus, Sumac
Brief summary
This study investigates the safety and combined effect of Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, Dog-rose, and Sumac on improving the glycemic profile of patients with type 2 diabetes mellitus compared to the placebo group.
Detailed description
The present double-blind, randomized and placebo-controlled study will be conducted on type 2 diabetes mellitus patients to evaluate the safety and combined effect of Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, Dog-rose, and Sumac on improving glycemic profiles (fasting blood sugar, glycosylated Hemoglobin, 2 hours postprandial blood sugar, insulin concentration, insulin resistance, and beta-cell function). The study also evaluates systolic blood pressure, diastolic blood pressure, anthropometric variables, lipid profile, C-reactive protein, and renal and liver function tests. A pilot study with 30 participants will be conducted to estimate the sample size considering 0.05 first type error and a power of 80%. Individuals aged between 18-70 with a diagnosis of type 2 diabetes mellitus based on WHO criteria for at least one year will be enrolled. Participants will be randomized in the placebo or intervention group to receive two capsules per day before lunch and dinner for six months containing 200 milligrams of equally combined extracts of Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, Dog-rose, and Sumac. Participants will be followed up with four office visits (t0= baseline, 1=15th day, 2t=3rd month, 3t=6th month) to assess outcomes. Also, the complications and adherence of patients to intervention will be checked every two weeks by telephonic discussion. The analysis will be performed based on the intent-to-treat method.
Interventions
COMBINATION_PRODUCTCapsules containing the combination products
Capsules containing dog-rose, Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, and Sumac
DRUGPlacebo capsules
Placebo capsules containing maltodextrin
Sponsors
Tabriz University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* At least one year of diagnosis of type 2 diabetes according to the criteria of the World Health Organization, * Hemoglobin A1c (HbA1c) \> 7.0% or fasting blood glucose \> 7.0 mmol/L, * Body mass index (BMI) more than 23 kg/m2 and less than 35.
Exclusion criteria
* Comorbidities, including type 1 diabetes, cardiovascular disease, thyroid disease, liver disease, kidney disease, cancer, mental disorders, and the use of drugs related to the aforementioned diseases, * Pregnancy, * Patients with a BMI over 35 who were on a weight loss diet or had taken weight loss supplements for less than 6 months * A history of allergy to one of the components of the nestling fruit, carob leaf, carob fruit, alfalfa seed, fenugreek seed, lemon, Nettles and sumac and also * Lactating women * Regularly consuming cigarettes or alcohol * Using psychiatric drugs or insulin * Changing in the medication regimen during the trial period. For example, to start receiving insulin therapy, become pregnant, or no longer follow medication and dietary instructions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting blood glucose | Day 0, 15, 90, 180 post intervention | Change in fasting blood glucose in response to intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c level | Day 0, 15, 90, 180 post intervention | Change in hemoglobin A1c level in response to intervention |
| High density lipoprotein (HDL) level | Day 0, 15, 90, 180 post intervention | Change in high density lipoprotein (HDL) level in response to intervention |
| Low density lipoprotein (LDL) level | Day 0, 15, 90, 180 post intervention | Change in low density lipoprotein (LDL) level in response to intervention |
| Triglyceride level | Day 0, 15, 90, 180 post intervention | Change in triglyceride level in response to intervention |
| Total cholesterol level | Day 0, 15, 90, 180 post intervention | Change in total cholesterol level in response to intervention |
| Aspartate transaminase level | Day 0, 15, 90, 180 post intervention | Change in aspartate transaminase level in response to intervention |
| Alanine aminotransferase level | Day 0, 15, 90, 180 post intervention | Change in alanine aminotransferase level in response to intervention |
| Insulin level | Day 0, 15, 90, 180 post intervention | Change in insulin level in response to intervention |
| Creatinine level | Day 0, 15, 90, 180 post intervention | Change in creatinine level in response to intervention |
| Prothrombin time | Day 0, 15, 90, 180 post intervention | Change in prothrombin time in response to intervention |
| Bilirubin level | Day 0, 15, 90, 180 post intervention | Change in bilirubin level in response to intervention |
| Ferritin level | Day 0, 15, 90, 180 post intervention | Change in ferritin level in response to intervention |
| Cholinesterase level | Day 0, 15, 90, 180 post intervention | Change in cholinesterase level in response to intervention |
| High-sensitivity C-reactive protein level | Day 0, 15, 90, 180 post intervention | Change in high-sensitivity C-reactive protein level in response to intervention |
| Blood urea nitrogen level | Day 0, 15, 90, 180 post intervention | Change in blood urea nitrogen level in response to intervention |
Countries
Iran
Contacts
Primary ContactSaeid Safiri, PhD
Outcome results
None listed