"The Effect of Comprehensive Non-pharmacological Treatment on Metabolic Disorders in Type 2 Diabetic Patients"
NCT ID: NCT04632823
Last Updated: 2020-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
100 participants
INTERVENTIONAL
2018-09-01
2021-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Comprehensive non-pharmacological program intervention
The experimental group receives usual diabetes care plus 24 weeks of the comprehensive non-pharmacological program intervention.
Comprehensive Non-pharmacological Treatment Program
dietary supplement, specific type of exercise, self-management education
Usual diabetes care
This group is control, the patients receive usual diabetes care routines.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Comprehensive Non-pharmacological Treatment Program
dietary supplement, specific type of exercise, self-management education
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
45 Years
59 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Astana Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Viktoriya Li
PhD, Head of Rehabilitation
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Viktoriya Li, PhD
Role: PRINCIPAL_INVESTIGATOR
Astana Medical University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
West Kazakhstan Marat Ospanov Medical University
Aktobe, Aktobe Region, Kazakhstan
Astana Medical University
Astana, , Kazakhstan
The Center for Preventive Medicine and Life Extension of Nur-Sultan
Astana, , Kazakhstan
National Medical Research Center for Endocrinology, Ministry of Health of the Russian Federation
Moscow, , Russia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Yerbolat Dalenov, Professor
Role: primary
Viktoriya Li, PhD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AstanaMU-1
Identifier Type: -
Identifier Source: org_study_id