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Effect of legumes consumption in patients with type 2 diabetes

Effect of substitution of meat with legumes in the dietary approach to stop hypertension diet on lipid profile, indices of glycemic, inflammation, coagulation, and oxidative stress in patients with type 2 diabetes according to genotype of rs7903146 in the TCF7L2

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20090203001640N17
Enrollment
300
Registered
2020-05-20
Start date
2020-07-05
Completion date
Unknown
Last updated
2020-06-15

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

Conditions

Condition 1: Type 2 diabetes. Condition 2: overweight and obesity. Diabetes mellitus due to underlying condition Overweight and obesity

Interventions

Intervention 1: Intervention group: Legume based dietary approach to stop hypertension diet with weight reduction. Intervention 2: Control group: Dietary approach to stop hypertension diet with weight

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 65 Years

Inclusion criteria

Inclusion criteria: Agreement to participate in the study and completing informed consent form Fasting blood glucose =126 mg/dl or 2-h plasma glucose =200 mg/dl or treatment with anti-hyperglycemic medications Aged 35-65 years old Body mass index between 25-40 kg/m2 No weight change in past three months determining transcription factor-7-like 2 rs7903146 genotypes

Exclusion criteria

Exclusion criteria: Cardiovascular disease such as myocardial infarction in past 6 months Renal disease (creatinine 1.4 = mg/dl for men or =1.3 mg/dl for women) Alcohol intake, either acute or chronic Using anti inflammatory drugs Following any specific diet in past three months Gastrointestinal disease (e.g. inflammatory bowel diseases) lower desire or lack of desire to consume legumes Insulin treatment Pregnant and lactating women

Design outcomes

Primary

MeasureTime frame
Fasting plasma glucose. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Enzymatic method.;High sensitive C reactive protein. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: ELISA.

Secondary

MeasureTime frame
Plasma concentration of total cholesterol. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Enzymatic method.;Plasma concentration of low density lipoprotein cholesterol. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Enzymatic method.;Plasma concentration of high density lipoprotein cholesterol. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Enzymatic method.;Plasma triglyceride concentration. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Enzymatic method.;Tumor necrosis factor alpha concentration. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Enzyme-linked immunosorbent assay.;Interleukin 6. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Enzyme-linked immunosorbent assay.;Fibrinogen concentration. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Turbiditymeter.;Plasma catalase activity. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Catalase activity assay kit.;Plasma insulin concentration. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Enzyme-linked immunosorbent assay.;Total antioxidant capacity. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Colorimetric.;Malondialdehyde concentration. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Colorimetric.;Systolic blood pressure. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Mercury sphygmomanometers.;Diastolic blood pressure. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Mercury sphygmomanometers.;Weight. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Scales.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSomayeh Hosseinpour

Shahid Beheshti University of Medical Sciences

s.hossainpour@yahoo.com+98 21 2243 2500

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 18, 2026