Diabetes Mellitus, Type 2
Conditions
Keywords
Colostrum, Diabetes Mellitus, Type 2, Cognition, Physical Functional Performance
Brief summary
The goal of this interventional Randomized clinical is to compare the effect of colostrum pharmaceutical preparation and placebo in a sample of Iraqi participants. The main questions to answer are: 1. What are the effects of the tested regimens on the level of IL-1 and IL-15. 2. What are the effects of the tested regimens on the Fasting Blood glucose? 3. What are the effects of the tested regimens on the HbA1C? 4. What are the effects of the tested regimens on the Body Mass Index? 5. What are the effects of the tested regimens on the Lipid profile? 6. What are the effects of the tested regimens on C-reactive protein? 7. What are the effects of the tested regimens on Hematological indices? 8. What are the effects of the tested regimens on Rate pressure product? Participants will be separated into four groups: 1. Group 1 (Healthy control): 24 Patients, will be receiving Placebo Capsule per oral once daily for 60 days 2. Group 2 (Healthy control) : 26 Patients, will be receiving Colostrum Capsule 500 mg per oral once daily for 60 days. 3. Group 3 (Diabetes Type 2): 23 Patieints, will be receiving Placebo Capsule per oral once daily for 60 days. 4. Group 4 (Diabetes Type 2) : 27 Patients, will be receiving Colostrum Capsule 500 mg per oral once daily for 60 days. Researchers will compare Groups 1,2,3, and 4 to observe the effect of the tested treatment regimens on IL-1, IL-6 ,Fasting Blood Glucose, HbA1c, Body Mass Index, Lipid profile, Rate pressure product, C-reactive protein, and Hematological indices. and use these measures In special formulas to determine the effect of the tested regimens on physical performance and cognitive function.
Interventions
Brand name: (Colostrum® 500 mg Veg Capsules) capsules per oral / once daily / 60 days duration.
OTHERPlacebo
Placebo Capsule / Capsules per oral / once daily / 60 days duration
Sponsors
Al-Mustafa University College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Apparently Healthy patients for control * Patients diagnosed with T2DM * Age between 18-70
Exclusion criteria
* Patients with T1DM * Patients with a drug history of anabolic substances for more than 14 days duration. * Patients with co-morbidities (e.g. CVS, renal, hepatic, and endocrine disorders) * Pregnancy, lactation, or female patient willing for conception.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum interleukin-15 (IL-15) Level | At Baseline, and After 60 days of treatment. | Measured in Pg/mL |
| Hemoglobin A1C (HbA1C) | At Baseline, and After 60 days of treatment. | Measured in percent from total Hemoglobin |
| Body Mass Index (BMI) | At baseline, and after 60 days of treatment | Measured in Kg/m² |
| Serum interleukin-1 (IL-1) Level | At Baseline, and After 60 days of treatment. | Measured in Pg/mL |
| Fasting Blood Sugar (FBS) | At Baseline, and After 60 days of treatment. | Measured in mg/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate Pressure Product | At baseline, and after 60 days of treatment. | Measured in an equation combining Heart rate in (BPM) and blood pressure in (mmHg) |
| Serum C-reactive protein (CRP) | At baseline, and after 60 days of treatment | Measured in mg/dL |
Countries
Iraq
Outcome results
None listed