NCT04632823

Brief Summary

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

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable type-2-diabetes

Geographic Reach
2 countries

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

2.4 years

First QC Date

November 9, 2020

Last Update Submit

November 16, 2020

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes mellitusnon-pharmacological treatmentlifestyle interventionstructured program

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline Glycosylated Hemoglobin at 6 months

    HbA1c value

    at baseline and at 24-week postrandomization

  • Change from Baseline Body Mass Index at 6 months

    BMI

    at baseline and at 24-week postrandomization

Secondary Outcomes (3)

  • Change from Baseline Blood Pressure at 6 months

    at baseline and at 24-week postrandomization

  • Change from Baseline Lipid Profiles at 6 months

    at baseline and at 24-week postrandomization

  • Change from Baseline Homeostasis ModelAssessment of Insulin Resistance at 6 months (HOMA-IR)

    at baseline and at 24-week postrandomization

Study Arms (2)

Comprehensive non-pharmacological program intervention

EXPERIMENTAL

The experimental group receives usual diabetes care plus 24 weeks of the comprehensive non-pharmacological program intervention.

Combination Product: Comprehensive Non-pharmacological Treatment Program

Usual diabetes care

NO INTERVENTION

This group is control, the patients receive usual diabetes care routines.

Interventions

Comprehensive Non-pharmacological Treatment ProgramCOMBINATION_PRODUCT

dietary supplement, specific type of exercise, self-management education

Comprehensive non-pharmacological program intervention

Eligibility Criteria

Age45 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

West Kazakhstan Marat Ospanov Medical University

Aktobe, Aktobe Region, 030000, Kazakhstan

ACTIVE NOT RECRUITING

Astana Medical University

Astana, 010000, Kazakhstan

RECRUITING

The Center for Preventive Medicine and Life Extension of Nur-Sultan

Astana, 010000, Kazakhstan

RECRUITING

National Medical Research Center for Endocrinology, Ministry of Health of the Russian Federation

Moscow, 101000, Russia

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Viktoriya Li, PhD

    Astana Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Viktoriya Li, PhD

CONTACT

+77785568055liviktoriya0509@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: prospective, single-center
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Head of Rehabilitation

Study Record Dates

First Submitted

November 9, 2020

First Posted

November 17, 2020

Study Start

September 1, 2018

Primary Completion

February 1, 2021

Study Completion

June 1, 2021

Last Updated

November 17, 2020

Record last verified: 2020-11

Locations

KA(3)RU(1)