Effect of lifestyle intervention on type 2 diabetes remissio

Not Applicable

Recruiting

• Conditions: Type 2 diabetes.; Type 2 diabetes mellitus

• Registration Number: IRCT20240418061519N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Men and women aged 18-50 years old
Less than 5 years duration of type 2 diabetes diagnosis
Use of at least one blood glucose-lowering medication
HbA1c more than 7.5%
Body mass index (BMI) 27-40 kg/m2

Exclusion Criteria

Use of insulin
Use of GLP-1 receptor agonist and sulfonylurea drugs
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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).