Effect of lifestyle intervention on type 2 diabetes remission

Comparison of cost-effectiveness, cost-utility, feasibility and the effect of intensive life style intervention based on an integrated behavioral model including two calorie-carbohydrate restricted diets and the combination of intermittent fasting diet with calorie-carbohydrate restriction on body composition and diabetes remission in patients with type 2 diabetes: a randomized controlled trial study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240418061519N1

Enrollment

120

Registered

2024-05-01

Start date

2024-05-21

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

Type 2 diabetes. Type 2 diabetes mellitus

Interventions

Intervention 1: First intervention group: calories-carbohydrates restricted diet group (CCR) Integrate

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Men and women aged 18-60 years old Less than 5 years duration of type 2 diabetes diagnosis Use of at least one blood glucose-lowering medication HbA1c more than 6.1% with use of blood glucose-lowering medication Body mass index (BMI) 27-40 kg/m2

Exclusion criteria

Exclusion criteria: Use of insulin Use of GLP-1 receptor agonist Recent routine HbA1c =10% Weight loss of more than 5 kg within the last 6 months Renal dysfunction (eGFR <60 ml/min) Uncontrolled blood pressure (more than 160 mm Hg systolic or more than 100 mm Hg diastolic) Known cancer Heart disease Active gout Diagnosed eating disorder Patients with confirmed mental disorders Current treatment with anti-obesity drugs History of bariatric surgery Currently pregnant or breastfeeding, or planning to become pregnant in the next 12 months Substance abuse Night shift workers Inability to perform physical activities

Design outcomes

Primary

Measure	Time frame
Changes in mean Hemoglobin A1C. Timepoint: Hemoglobin A1C measurement at the beginning of the study, three and six months after the start of the intervention. Method of measurement: High-performance liquid chromatography.;Body weight. Timepoint: Body weight measurement at the beginning of the study, three and six months after the start of the intervention. Method of measurement: Bioelectrical impedance analysis (TANITA BC-418).;Body Fat Mass. Timepoint: Body Fat Mass measurement at the beginning of the study, three and six months after the start of the intervention. Method of measurement: Bioelectrical impedance analysis (TANITA BC-418).;Fat Free Mass. Timepoint: Fat Free Mass measurement at the beginning of the study, three and six months after the start of the intervention. Method of measurement: Bioelectrical impedance analysis (TANITA BC-418).	—

Measure

Time frame

Changes in mean Hemoglobin A1C. Timepoint: Hemoglobin A1C measurement at the beginning of the study, three and six months after the start of the intervention. Method of measurement: High-performance liquid chromatography.;Body weight. Timepoint: Body weight measurement at the beginning of the study, three and six months after the start of the intervention. Method of measurement: Bioelectrical impedance analysis (TANITA BC-418).;Body Fat Mass. Timepoint: Body Fat Mass measurement at the beginning of the study, three and six months after the start of the intervention. Method of measurement: Bioelectrical impedance analysis (TANITA BC-418).;Fat Free Mass. Timepoint: Fat Free Mass measurement at the beginning of the study, three and six months after the start of the intervention. Method of measurement: Bioelectrical impedance analysis (TANITA BC-418).

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Secondary

Measure	Time frame
Fasting blood glucose. Timepoint: Fasting blood glucose measurement at the beginning of the study, three and six months after the start of the intervention. Method of measurement: Glucose oxidase.;Fasting insulin. Timepoint: Fasting insulin measurement at the beginning of the study, three and six months after the start of the intervention. Method of measurement: chemiluminescence.;Insulin resistance index. Timepoint: Insulin resistance index calculating at the beginning of the study, three and six months after the start of the intervention. Method of measurement: Using the formula.;Serum triglyceride. Timepoint: Serum triglyceride measurement at the beginning of the study, three and six months after the start of the intervention. Method of measurement: Photometric.;Total serum cholesterol. Timepoint: Total serum cholesterol measurement at the beginning of the study, three and six months after the start of the intervention. Method of measurement: Photometric.;Serum low-density lipoprotein (LDL). Timepoint: Serum low-density lipoprotein (LDL) measurement at the beginning of the study, three and six months after the start of the intervention. Method of measurement: Photometric.;Serum High-density Lipoprotein (HDL). Timepoint: Serum High-density Lipoprotein (HDL) measurement at the beginning of the study, three and six months after the start of the intervention. Method of measurement: Photometric.;Physical activity score. Timepoint: Physical activity score measurement at the beginning of the study, three and six months after the start of the intervention. Method of measurement: Physical activity record questionnaire.;Average percentage of feasibility. Timepoint: Average percentage of feasibility measurement three and six months after the start of the intervention. Method of measurement: Feasibility questionnaire.;Quality-adjusted life year (QALY) score. Timepoint: Quality-adjusted life year (QALY) score measurement at the beginning of the study, three and six months af	—

Measure

Time frame

Fasting blood glucose. Timepoint: Fasting blood glucose measurement at the beginning of the study, three and six months after the start of the intervention. Method of measurement: Glucose oxidase.;Fasting insulin. Timepoint: Fasting insulin measurement at the beginning of the study, three and six months after the start of the intervention. Method of measurement: chemiluminescence.;Insulin resistance index. Timepoint: Insulin resistance index calculating at the beginning of the study, three and six months after the start of the intervention. Method of measurement: Using the formula.;Serum triglyceride. Timepoint: Serum triglyceride measurement at the beginning of the study, three and six months after the start of the intervention. Method of measurement: Photometric.;Total serum cholesterol. Timepoint: Total serum cholesterol measurement at the beginning of the study, three and six months after the start of the intervention. Method of measurement: Photometric.;Serum low-density lipoprotein (LDL). Timepoint: Serum low-density lipoprotein (LDL) measurement at the beginning of the study, three and six months after the start of the intervention. Method of measurement: Photometric.;Serum High-density Lipoprotein (HDL). Timepoint: Serum High-density Lipoprotein (HDL) measurement at the beginning of the study, three and six months after the start of the intervention. Method of measurement: Photometric.;Physical activity score. Timepoint: Physical activity score measurement at the beginning of the study, three and six months after the start of the intervention. Method of measurement: Physical activity record questionnaire.;Average percentage of feasibility. Timepoint: Average percentage of feasibility measurement three and six months after the start of the intervention. Method of measurement: Feasibility questionnaire.;Quality-adjusted life year (QALY) score. Timepoint: Quality-adjusted life year (QALY) score measurement at the beginning of the study, three and six months af

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNegin Badrooj

Tehran University of Medical Sciences

badroojnegin@yahoo.com+98 21 8895 5814

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Apr 13, 2026