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The effect of a low calorie diet in patients with type 2 diabetes

The effect of a low calorie diet on metabolic status in normal and overweight patients with type 2 diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20170214032571N10
Enrollment
120
Registered
2019-07-28
Start date
2018-06-21
Completion date
Unknown
Last updated
2019-10-07

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

Conditions

Type 2 diabetes. E11

Interventions

Intervention 1: Intervention group: Group A =Intervention in normal weight diabetes patients by reducing 500kcal of daily energy requirement for 12 months. Intervention 2: Intervention group: Group B

Sponsors

Oroumia University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Criteria for inclusion in the study: normal and overweight patients with type 2 diabetes Aged between 18 to 65 Consumption of same drugs (glibenclamide, metformin)

Exclusion criteria

Exclusion criteria: Criteria for exclusion from the study: Suffering from liver diseases Suffering from thyroid disease Pregnancy and lactation Smoking and drinking alcohol Consumption of drugs reducing blood fat and pressure and Weight, thiazide diuretics and corticosteroids Change of type and dosage of consuming drugs during the study Consumption of Herbal or chemical supplements Suffering from Digestive diseases associated with malabsorption Gastric bypass surgery and cholecystectomy Insulin Therapy people who have been on weight loss diet or had been treated with drugs and supplements related to weight loss (such as Orlistat or Slim Last dietary supplements) in the past three months Suffering from diabetic complications such as nephropathy, retinopathy, neuropathy and cardiovascular complications

Design outcomes

Primary

MeasureTime frame
Insulin resistance. Timepoint: At weeks 0, 12. Method of measurement: (fasting serum glucose (mmol/L) × fasting serum insulin (µIU/ml))/22.5.;Quantitative Insulin Sensitivity Check Index. Timepoint: At weeks 0, 12. Method of measurement: 1/ [ log(fasting insulin, µU/ml) + log (fasting glucose, mg/dl) ].;Fasting Blood Sugar. Timepoint: At weeks 0, 12. Method of measurement: Enzymatic method, mg/dl.;Serum insulin. Timepoint: At weeks 0, 12. Method of measurement: Radioimmunoassay.;Systolic blood pressure. Timepoint: At weeks 0, 12. Method of measurement: Mercury pressure gauge, Mm mercury.;Diastolic blood pressure. Timepoint: At weeks 0, 12. Method of measurement: Mercury pressure gauge, Mm mercury.;Body composition analysis (Weight, Body mass index, Fat mass, Fat free mass, Visceral fat area, Waist circle, Waist to hip ratio, Skeletal muscle mass). Timepoint: At weeks 0, 12. Method of measurement: Inbody770 Body Analyzer, Bioelectrical impedance analysis.;HbA1c. Timepoint: At weeks 0, 12. Method of measurement: Enzymatic method, %.;Lipid profile (Triglyceride,Total cholesterol, VLDL, LDL, HDL?). Timepoint: At weeks 0, 12. Method of measurement: Enzymatic method, mg / dl.;Liver enzymes (ALP, ALT, AST). Timepoint: At weeks 0, 12. Method of measurement: Enzymatic method, IU/L.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMajid Monafi

Oroumia University of Medical Sciences

majidmanafi@yahoo.com+98 44 1278 0803

Outcome results

None listed

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