Type 2 Diabetes Mellitus. Type 2 diabetes mellitus
Conditions
Interventions
Intervention 1: Intervention group: This study of patients with type 2 diabetes referred to the Shar hospital, Sulaymaniyah, Iraq, which has the inclusion criteria, at the beginning of the study goals
containing starch and inactive ingredient excipients) The placebo capsules will be produced and coded by Takgene Zist pharmaceutical company.• The packaging, odor, and appearance of placebo containing
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
50 Years to 65 Years
Inclusion criteria
Inclusion criteria: Age between50 - 65 years Type 2 diabetic patients that diagnosed at least 2 years ago. BMI between 25 – 34.9 kg/m2 The patient or caregiver understands the objectives of the study and agrees to follow the necessary rules throughout the study.
Exclusion criteria
Exclusion criteria: Irregular diet and unstable body weight (body-weight change > 5% within 3 months before screening) Type 1 diabetes or non-diabetic patients History of Cardiovascular disease, Hypertension, heart attack, angina pectoris, cerebrovascular disease, stroke, Thyroid disease, and other chronic diseases and transmitted diseases in the past year. Dietary supplementation of probiotics within 6 months before screening Pregnancy or breast-feeding Use of smoke and alcohol during the last three months prior the study. Consumption of medication that affects body weight, energy expenditure, glucose control, or antibiotic treatment within 3 months before screening. using any drug other than metformin, sulfonylurea, statins, angiotensin-converting enzyme inhibitors (ACEI), angiotensin receptor blockers (ARB), and aspirin at doses of 80?mg or less Changing in medications received in the previous three months. Having any allergic reaction after our intervention. Participants who consume less than 80% of the supplement. Further exclusion criteria are acute or chronic infections, liver disease, kidney disease, gastrointestinal disease, or any other acute or chronic disease requiring treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lipoprotein-associated phospholipase A2 (Lp-PLA2). Timepoint: before intervention and 12 weeks after intervention. Method of measurement: using a lab kit to measure Lp-PLA2. | — |
Secondary
| Measure | Time frame |
|---|---|
| Glycemic Index(Fasting Blood Sugar, Glycosylated Hemoglobin). Timepoint: before intervention and 12 weeks after intervention. Method of measurement: enzymatic colorimetric method.;Lipid Profile (TC, TG, HDL, LDL). Timepoint: before intervention and 12 weeks after intervention. Method of measurement: enzymatic colorimetric method.;HOMA-IR. Timepoint: before intervention and 12 weeks after intervention. Method of measurement: Calculating by formula: HOMA-IR=(glucose(mg/dl)× Insulin(µU/ml))/22.5.;Weight. Timepoint: before intervention and 12 weeks after intervention. Method of measurement: standard scale.;Waist circumference. Timepoint: before intervention and 12 weeks after intervention. Method of measurement: non-stretching tape.;Body composition. Timepoint: before intervention and 12 weeks after intervention. Method of measurement: Bioelectrical Impedance Analysis. | — |
Countries
Iraq
Contacts
Public ContactSalman Salih Mohammed Jaff
Tehran University of Medical Sciences
Outcome results
None listed