Effect of Crocin and Metformin in patients with type 2 diabetes

Exploring the effect of Crocin supplementation on glycemic indexes, oxidative stress factors and inflammation biomarkers in patients with type 2 diabetes treated by metformin

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170611034458N2

Enrollment

Registered

2022-02-11

Start date

2022-01-15

Completion date

Unknown

Last updated

2024-05-27

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

Conditions

Type 2 Diabetes. Type 2 diabetes mellitus

Interventions

Intervention 1: Intervention group: Crocin supplementation: they will receive, for 12 weeks, two tablets of Crocin (Samisaz Company) per day, each containing 15 mg of crocin. Intervention 2: Control g

Eligibility

Sex/Gender

All

Age

35 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes treated by metformin Aged 35-75 years old

Exclusion criteria

Exclusion criteria: Hypertension Patients with other endocrine, liver, kidney, inflammatory and lung disorders Taking metformin in combination with other anti-diabetic drugs Take any other antioxidant supplement Alcohol-drug abuse Pregnant women Patients with type 1 diabetes

Design outcomes

Primary

Measure	Time frame
Fasting blood sugar. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: Enzymatic assay kit.;Serum concentrations of insulin. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: ELISA kit.;Hemoglobin A1C levels. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: Enzymatic assay kit.;HOMA-IR. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: Using available formulas.	—

Measure

Time frame

Fasting blood sugar. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: Enzymatic assay kit.;Serum concentrations of insulin. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: ELISA kit.;Hemoglobin A1C levels. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: Enzymatic assay kit.;HOMA-IR. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: Using available formulas.

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Secondary

Measure	Time frame
Serum concentrations of triglyceride. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: Enzymatic assay kit.;HDL-C cholesterol. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: Enzymatic assay kit.;Total cholesterol. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: Enzymatic assay kit.;LDL cholesterol. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: Enzymatic assay kit.;Serum concentration of Total antioxidant capacity (TAC). Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: Spectrophotometry.;Serum concentrations of high sensitivity c-reactive protein (hs-CRP). Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: ELISA kit.;Malondialdehyde. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: Spectrophotometry.;Glutathione. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: Spectrophotometry.;Superoxide dismutase (SOD ) activity. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: ELISA kit.;Catalase activity. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: ELISA kit.;Protein Carbonyl Concentration. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: Spectrophotometry.;Advanced glycosylation end-products. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of mea	—

Measure

Time frame

Serum concentrations of triglyceride. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: Enzymatic assay kit.;HDL-C cholesterol. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: Enzymatic assay kit.;Total cholesterol. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: Enzymatic assay kit.;LDL cholesterol. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: Enzymatic assay kit.;Serum concentration of Total antioxidant capacity (TAC). Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: Spectrophotometry.;Serum concentrations of high sensitivity c-reactive protein (hs-CRP). Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: ELISA kit.;Malondialdehyde. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: Spectrophotometry.;Glutathione. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: Spectrophotometry.;Superoxide dismutase (SOD ) activity. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: ELISA kit.;Catalase activity. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: ELISA kit.;Protein Carbonyl Concentration. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of measurement: Spectrophotometry.;Advanced glycosylation end-products. Timepoint: Initially (before the intervention) and at the end (12 weeks after the intervention). Method of mea

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Hosein Araabi

Esfahan University of Medical Sciences

Mh.aarabi@pharm.mui.ac.ir+98 31 3792 7052

Outcome results

None listed

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