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Dietary energy density and type 2 diabetes

Comparative effects of high versus low energy-dense diets on serum levels of adipokines and inflammatory biomarkers in type 2 diabetic women

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201105281485N4
Enrollment
60
Registered
2011-06-13
Start date
2010-11-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

diabetes. ????? ??? 2 ? ???? ?????????? ??????? ??? ?????? ??????? ??? 2

Interventions

Intervention 1: High-energy dense diet : High-energy dense diet would be a weight loss diet (-500kcal)diet. this diet containing 45-50% of energy from carbohydrates, 35% from fats and 15-20% from prot
Treatment - Other
High-energy dense diet : High-energy dense diet would be a weight loss diet (-500kcal)diet. this diet containing 45-50% of energy from carbohydrates, 35% from fats and 15-20% from proteins. Individua
low energy dense diet: Low-energy dense diet would be a weight loss diet (-500kcal)diet.this diet containing 50-60% of energy from carbohydrates, 25% from fats and 15-20% from proteins. Indiv
normal diet:normal diet would be a weight loss diet (-500kcal)diet.this diet containing 50-55% of energy from carbohydrates, 30% from fats and 15-20% from proteins.

Sponsors

Vice chancellor for research,Isfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
30 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Diabetic non-pregnant and non-lactating females aged 30-60 y, Lack of insulin injection, non-smokers, lack of having a special diet except for usual diabetes meal plan, lack of sever weight loss in the last 3 months, not having sever infection in the last 3 months, trauma, surgery, hypo- and hyper-thyroidism, lack of the use of vasodialators, antioxidant supplements, vitamin and mineral supplements, diuretics, betablockers, garlet, OCP, aspirine and corticosteroids. Exclusion criteria: Lack of adherence to the prescribed diet, starting the use of above-mentioned medications or affecting by the above-mentioned diseases, alterations in dosage and type of current medications, getting pregnant

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Serum visfatin level. Timepoint: before the intervention week 8. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA) ?ng/dL.;Serum adiponectin level. Timepoint: before the intervention week 8. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA) ?ug/dL.;Serum chemerin level. Timepoint: before the intervention week 8. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA) ?ng/dL.;Serum high sensitive Interleukin 6 (hs IL-6) levels. Timepoint: before intervention and week 8. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA) ?ng/dL.;Serum high sensitive tumor necrosis factor-alpha (hs TNF-a) levels. Timepoint: before intervention and week 8. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA) ?mg/dL.;Serum high sensitive-C Reactive Protein (hs-CRP) levels. Timepoint: before the intervention week 8. Method of measurement: high sensitive immunoturbidimetry, mg/dL.

Secondary

MeasureTime frame
Hip circumference. Timepoint: before the intervention week 8. Method of measurement: centimeter, meter.;Body mass index. Timepoint: before the intervention week 8. Method of measurement: kg/m2, Weight/Height square.;Waist circumference. Timepoint: before the intervention week 8. Method of measurement: meter, centimeter.;Weight. Timepoint: before the intervention week 8. Method of measurement: scale, kilogram.;Fasting blood sugar. Timepoint: before the intervention week 8. Method of measurement: mg/dL, Colorimetric.;Serum insulin levels. Timepoint: before the intervention week 8. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA)?µU/mL.;Serum Triglyceride levels. Timepoint: before the intervention week 8. Method of measurement: photometrics, mg/dL.;Serum total cholesterol levels. Timepoint: before the intervention week 8. Method of measurement: photometrics, mg/dL.;Serum Low-Density Lipoprotein cholesterol (LDL-c) levels. Timepoint: before the intervention week 8. Method of measurement: Enzymatic, mg/dL.;Serum High-Density Lipoprotein cholesterol (HDL-c) levels. Timepoint: before the intervention week 8. Method of measurement: photometrics, mg/dL.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAhmad Esmaillzadeh

Isfahan University of Medical Sciences

esmaillzadeh@hlth.mui.ac.ir+98 31 1792 2720

Outcome results

None listed

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