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The effects of melatonin supplementation on lipid profile, glycemic index, oxidative stress and inflammatory biomarkers in obese patients with type 2 diabetes

The effects of melatonin supplementation on lipid profile, glycemic index, oxidative stress and inflammatory biomarkers in obese patients with type 2 diabetes

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20170202032367N11
Enrollment
46
Registered
2025-03-16
Start date
2024-11-21
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Non-insulin-dependent type 2 diabetes. Diabetes mellitus due to underlying condition

Interventions

Intervention 1: Intervention group: Intervention group: Before starting the main intervention, all the selected people enter the Run-in period for two weeks, to collect complete information about the

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 60 Years

Inclusion criteria

Inclusion criteria: At least 6 months and a maximum of 10 years have passed since the diagnosis of the disease by a doctor. Having diabetes diagnosed based on laboratory findings and the opinion of an endocrinologist. Willingness to cooperate in this study Age above 30 and less than 60 years Body mass index above 30 and below 40 kg/m2 Patients who are not candidates for bariatric surgery

Exclusion criteria

Exclusion criteria: At least 6 months and at most 10 years have passed since the diagnosis of the disease by a doctor. Having diabetes diagnosed based on laboratory findings and the opinion of an endocrinologist. Being willing to cooperate in this study Being willing to cooperate in this study Body mass index above 30 and below 40 kg/m2 Patients who are not candidates for bariatric surgery

Design outcomes

Primary

MeasureTime frame
Serum levels of lipid parameters (T.G, T.C, LDL, HDL). Timepoint: Before the intervention and 12 weeks later. Method of measurement: Pars test kit and spectrophotometry method.;Serum levels of blood sugar profiles (FBS, HbA1C, HOMA-IR, HOMA-B). Timepoint: Before the intervention and 12 weeks later. Method of measurement: Diagnostic kits.;Serum levels of oxidative stress markers (MDA). Timepoint: Before the intervention and 12 weeks later. Method of measurement: Pars test kit and spectrophotometry method.;Serum levels of inflammatory markers (hs-CRP, IL-6, TNF-a). Timepoint: Before the intervention and 12 weeks later. Method of measurement: kit Eliza.

Secondary

MeasureTime frame
Systolic and diastolic blood pressure. Timepoint: Before the intervention and 12 weeks later. Method of measurement: Sphygmomanometer and calibrated stethoscope.;Sleep quality score. Timepoint: Before the intervention and 12 weeks later. Method of measurement: Sleep quality questionnaire.;Carbohydrate, protein, fat and fiber intake. Timepoint: Before the intervention and 12 weeks later. Method of measurement: 24-hour food recall questionnaire.;New anthropometric indices (Tyg, WT, VAI, WT). Timepoint: Before the intervention and 12 weeks later. Method of measurement: Calculate.;Calculating the risk of chronic diseases using the ASCVD and Framingham criteria. Timepoint: Before the intervention and 12 weeks later. Method of measurement: Calculate.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHossein Imani

Tehran University of Medical Sciences

h_imani@sina.tums.ac.ir+9821889900285

Outcome results

None listed

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