Evaluating the Effect of Synbiotic Supplements on type 2 Diabetes

Phase 3

Conditions: Diabetes mellitus.
Diabetes mellitus without complications
E14.9

Registration Number: IRCT20230212057393N2

Lead Sponsor: Mazandaran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 194

Inclusion Criteria

All patients in the age group of 30 to 75 years with type 2 diabetes who are diagnosed based on the latest American Diabetes Association(ADA) guidelines.

Exclusion Criteria

Pregnant and lactating women
Patients receiving hormone therapy, including estrogen and progesterone.
Hypothyroidism
Patients with kidney disease that have a creatinine level more than two times the upper normal limit.
Consumption of any Probiotic, Synbiotic products and Antibiotics in the last three months.
Alcohol consumption

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hyperglycemia. Timepoint: In the beginning, and after three months. Method of measurement: Test kit for measuring blood sugar.;Insulin Resistance. Timepoint: In the beginning, and after three months. Method of measurement: ELISA Insulin Kit.

Secondary Outcome Measures

Name	Time	Method
ipid Profiles. Timepoint: At the Baseline and three months after entering the trial. Method of measurement: Blood test.;Body Mass Index. Timepoint: At the Baseline and three months after entering the Trial. Method of measurement: Scale and Tape Measure.;Systolic and Diastolic Blood Pressure. Timepoint: At the baseline and three months after entering the Trial. Method of measurement: Mercury Sphygmomanometer.;Measure psychological disorder. Timepoint: At the baseline and three months after entering the trial. Method of measurement: The General Health Questionnaire – 28.;Appetite assessment. Timepoint: At the Baseline and every month after entering the trial. Method of measurement: Question by the research team by phone.;Evaluating the stool condition of patients. Timepoint: At the Baseline and every month after entering the trial. Method of measurement: Question by the research team by phone.