Clinical trial NCT04632823: "The Effect of Comprehensive Non-pharmacological Treatment on Metabolic Disorders in Type 2 Diabetic Patients"
Official title: "The Effect of Comprehensive Non-pharmacological Treatment on Metabolic Disorders in Type 2 Diabetic Patients"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes mellitus
non-pharmacological treatment
lifestyle intervention
structured program
Lead sponsor: Astana Medical University
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, single-center
Primary purpose: TREATMENT

Brief summary: Evaluation of the effectiveness of comprehensive non-pharmacological treatment on metabolic disorders in type 2 diabetic patients

Detailed description: Patients in the intervention group will participate in a comprehensive non-pharmacological treatment of type 2 diabetes, the main components are:

* changing the meal plan (individual and group counseling, assistance in developing menus and determining the calorie intake, keeping a food diary)
* individually dosed physical exercises using specific exercise program;
* comprehensive training (course of interactive lessons, self-control training). The program included group sessions with a team of specialists: nutritionist, endocrinologist, physical therapy doctor and included 3 sessions per week for 24 weeks. Each visit included teaching patients in a group format and in an interactive form (classes with specialists alternated), performing physical exercises using the specific exercise program under the supervision of a physiotherapy physician, evaluating medical indicators, and a self-control diary.

Patients in the control group will not participate in group sessions, but they had the opportunity to receive non-pharmacological care provided in the framework of free outpatient care. Their indicators will be recorded during a routine visit to the doctor at the baseline, after 12 and 24 weeks.

Eligibility criteria: Inclusion Criteria:

* medically diagnosed with type 2 diabetes mellitus
* HbA1c result of ≤7.0% within the past 2 months
* body mass index (BMI) of ≥26 kg/m\^2
* hypoglycemic therapy: metformin only

Exclusion Criteria:

* pregnancy
* the use of other hypoglycemic drugs
* the use of medication for weight loss
* cardiovascular diseases (heart attack or cardiac procedure within the past 3 months)
* had stroke or history of treatment for transient ischemic attacks in the past 3 months
* had chronic renal failure or were on dialysis
* any conditions that do not allow the patient to perform the complex of the proposed physical exercises

Primary outcomes:
measure: Change from Baseline Glycosylated Hemoglobin at 6 months
timeFrame: at baseline and at 24-week postrandomization
measure: Change from Baseline Body Mass Index at 6 months
timeFrame: at baseline and at 24-week postrandomization
Secondary outcomes:
measure: Change from Baseline Blood Pressure at 6 months
timeFrame: at baseline and at 24-week postrandomization
measure: Change from Baseline Lipid Profiles at 6 months
timeFrame: at baseline and at 24-week postrandomization
measure: Change from Baseline Homeostasis ModelAssessment of Insulin Resistance at 6 months (HOMA-IR)
timeFrame: at baseline and at 24-week postrandomization
Other outcomes:
Locations:
city: Aktobe
country: Kazakhstan
facility: West Kazakhstan Marat Ospanov Medical University
state: Aktobe Region
city: Astana
country: Kazakhstan
facility: Astana Medical University
city: Astana
country: Kazakhstan
facility: The Center for Preventive Medicine and Life Extension of Nur-Sultan
city: Moscow
country: Russian Federation
facility: National Medical Research Center for Endocrinology, Ministry of Health of the Russian Federation
Study officials:
affiliation: Astana Medical University
name: Viktoriya Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: