The effect of LRE90 on glycemic control in diabetic patients

Evaluation of the effect of LRE90 (with usual diabetes medications) on blood glucose control in type 2 diabetic patients: A placebo-controlled double-blind clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200716048118N2

Enrollment

Registered

2021-01-25

Start date

2021-01-20

Completion date

Unknown

Last updated

2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Daibetes type 2. Diabetes mellitus due to underlying condition

Interventions

Intervention 1: Intervention group: In this group patients take their oral diabetes medications without any changes and in addition, they receive treatment with LRE90 including 10 cc of LRE90 solution

Eligibility

Sex/Gender

All

Age

30 Years to 70 Years

Inclusion criteria

Inclusion criteria: Diabetes diagnosis HbA1c between 7.5 and 9% Age between 30 and 70years

Exclusion criteria

Exclusion criteria: Chronic liver failure, Chronic renal failure, pregnancy, lactation, insulin therapy

Design outcomes

Primary

Measure	Time frame
FBS. Timepoint: Before beginning and after completing the study (week zero and after the end of 12 th weeks). Method of measurement: Calorimetry.;HbA1c. Timepoint: Before beginning and after 12 weeks of study. Method of measurement: HPLC.;Total cholestrol. Timepoint: Before beginning and after 12 weeks of treatment. Method of measurement: Calorimetry.;Triglyceride. Timepoint: Before beginning and after 12 weeks of treatment. Method of measurement: Calorimerty.;LDL-Cholesterol. Timepoint: Before beginning and after 12 weeks of treatment. Method of measurement: Direct method.;HDL-Cholesterol. Timepoint: Before beginning and after 12 weeks of treatment. Method of measurement: Caloorimetry.;ALT. Timepoint: Before beginning and after 12 weeks of treatment. Method of measurement: Calorimetry.;AST. Timepoint: Before beginning and after 12 weeks of treatment. Method of measurement: Calorimetry.;AKP. Timepoint: Before beginning and after 12 weeks of treatment. Method of measurement: Calorimetry.;Serum Creatinine. Timepoint: Before beginning and after 12 weeks of treatment. Method of measurement: Calorimetry.	—

Measure

Time frame

FBS. Timepoint: Before beginning and after completing the study (week zero and after the end of 12 th weeks). Method of measurement: Calorimetry.;HbA1c. Timepoint: Before beginning and after 12 weeks of study. Method of measurement: HPLC.;Total cholestrol. Timepoint: Before beginning and after 12 weeks of treatment. Method of measurement: Calorimetry.;Triglyceride. Timepoint: Before beginning and after 12 weeks of treatment. Method of measurement: Calorimerty.;LDL-Cholesterol. Timepoint: Before beginning and after 12 weeks of treatment. Method of measurement: Direct method.;HDL-Cholesterol. Timepoint: Before beginning and after 12 weeks of treatment. Method of measurement: Caloorimetry.;ALT. Timepoint: Before beginning and after 12 weeks of treatment. Method of measurement: Calorimetry.;AST. Timepoint: Before beginning and after 12 weeks of treatment. Method of measurement: Calorimetry.;AKP. Timepoint: Before beginning and after 12 weeks of treatment. Method of measurement: Calorimetry.;Serum Creatinine. Timepoint: Before beginning and after 12 weeks of treatment. Method of measurement: Calorimetry.

—

Secondary

Measure	Time frame
Lipid profile. Timepoint: beginning and end of study. Method of measurement: Biochemical.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Bandarian

Tehran University of Medical Sciences

fbandarian@tums.ac.ir+98 21 8833 8742

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026