Type 2 Diabetes. Type 2 diabetes mellitus
Conditions
Interventions
Intervention 1: Intervention group: (CCR – Continuous Calorie and Carbohydrate Restriction): Participants receive a diabetes self-management program including in-person education, telephone counseling
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Men and women aged 18 to 50 years Diagnosis of type 2 diabetes mellitus with a disease duration of less than 2 years Diagnosis of type 2 diabetes confirmed by at least two documented diagnostic tests (HbA1c and/or blood glucose) Use of at least one glucose-lowering medication HbA1c level greater than 43 mmol/mol (= 6.1%) despite the use of glucose-lowering medications Body mass index (BMI) between 27 and 45 kg/m²
Exclusion criteria
Exclusion criteria: Current use of insulin Recent routine HbA1c level = 9% Weight loss greater than 5 kg during the past 6 months Impaired renal function with an eGFR < 60 mL/min Uncontrolled hypertension (systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg) History of any type of cancer Presence of cardiovascular disease History of gout Diagnosed eating disorders Confirmed psychiatric disorders Current treatment with anti-obesity medications History of bariatric surgery Current pregnancy or breastfeeding, or planning pregnancy within the next 12 months Substance abuse Night shift workers Inability to perform physical activities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Branched-chain amino acids (BCAAs). Timepoint: At baseline (before initiation of the intervention) At the end of the intervention period (after 3 months of follow-up). Method of measurement: Plasma levels of branched-chain amino acids including leucine, isoleucine, and valine are measured from venous blood samples collected after twelve to fourteen hours of fasting. Plasma is separated by centrifugation and derivatized using S-carboxymethyl-L-cysteine as an internal standard. Quantitative analysis is performed using high performance liquid chromatography with an Agilent one thousand one hundred system. Primary amino acids are derivatized with o-phthalaldehyde and three-mercaptopropionic acid, while secondary amino acids are derivatized with nine-fluorenylmethyl chloroformate, and detection is carried out using diode array and fluorescence detectors. | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting Plasma Glucose. Timepoint: At baseline and at the end of the 3-month intervention. Method of measurement: Measurement of fasting plasma glucose using the glucose oxidase method.;Glycated Hemoglobin (HbA1c). Timepoint: At baseline and at the end of the 3-month intervention. Method of measurement: Measurement of glycated hemoglobin using Pars Azmoon kit.;Serum Triglycerides. Timepoint: At baseline and at the end of the 3-month intervention. Method of measurement: Measurement of serum triglycerides using photometric method.;Total Serum Cholesterol. Timepoint: At baseline and at the end of the 3-month intervention. Method of measurement: Measurement of total serum cholesterol using photometric method.;High Density Lipoprotein Cholesterol. Timepoint: At baseline and at the end of the 3-month intervention. Method of measurement: Measurement of high density lipoprotein cholesterol using photometric method.;Systolic Blood Pressure. Timepoint: At baseline and at the end of the 3-month intervention. Method of measurement: Measurement of systolic blood pressure in the seated position using a standard sphygmomanometer.;Body Weight. Timepoint: At baseline and at the end of the 3-month intervention. Method of measurement: Measurement of body weight with minimal clothing and without shoes using Seca scale.;Interleukin Six. Timepoint: At baseline and at the end of the 3-month intervention. Method of measurement: Measurement of serum interleukin six using ELISA kit.;Interleukin Ten. Timepoint: At baseline and at the end of the 3-month intervention. Method of measurement: Measurement of serum interleukin ten using ELISA kit.;Tumor Necrosis Factor Alpha. Timepoint: At baseline and at the end of the 3-month intervention. Method of measurement: Measurement of serum tumor necrosis factor alpha using ELISA kit.;High Sensitivity C Reactive Protein. Timepoint: At baseline and at the end of the 3-month intervention. Method of measurement: Measurement of serum high sensitivity C react | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSakineh Shabbidar
Tehran University of Medical Sciences
Outcome results
None listed