T2DM Intensity Lifestyle Intervention

Status Completed

Clinical Trial Summary

This RCT study will evaluate the effect of a lifestyle intervention on overweight or obese patients with type 2 diabetes mellitus. The primary hypothesis is that the mHealth-based intensive lifestyle intervention is sufficient to achieve weight loss and maintain glycated hemoglobin control.

Clinical Trial Description

Diabetes mellitus is a chronic systemic metabolic disease caused by the long-term interaction of genetic factors and environmental factors. It is characterized by an increase in plasma glucose levels and is mainly due to metabolic disorders in glucose, fat, and protein caused by insufficient insulin secretion and/or dysfunction in the body, which affects normal physiological activities. As of 2019, 463 million people are suffering from diabetes in the world, of which 90% to 95% have type 2 diabetes mellitus (T2DM), with an average of 1 patient in every 11 adults (aged 20-79). The number of patients with T2DM will jump to 700 million by 2045. There is a close relationship between T2DM and overweight and obesity. The prevalence of diabetes in overweight and obese people in China was 12.8% and 18.5%, respectively. Among T2DM patients, the proportions of overweight and obesity were 41% and 24.3%, respectively.The two kinds of diseases share a common key pathophysiological mechanism, which will have a devastating long-term impact on patients' health and bring serious disease and economic burden to the family. Given the various harms, it is urgent to carry out relevant intervention research and formulate effective intervention strategies. With the development of artificial intelligence technology, the combination of mHealth and multidisciplinary lifestyle intervention may become an efficient and easy-to-popularize management mode for the prevention and treatment of T2DM with obesity. Given the relative lack of high-quality interventions for T2DM overweight/obesity, the investigators designed a randomized controlled trial to assess the effectiveness of a multicomponent intervention in Ningbo First Hospital. This study plans to adopt the online and offline combination method based on mHealth technology to carry out lifestyle intervention aimed at formulating a set of feasible and effective intervention strategies. The study aims to identify: 1) whether the mHealth-based intensive lifestyle intervention will be effective for weight and glycated hemoglobin management to reverse or slow down the disease process among T2DM patients with overweight/obesity; 2) whether the intervention will be beneficial for improving biochemical indicators, body composition indicators, and exercise capacity among T2DM patients with overweight/obesity. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05561855
Study type	Interventional
Source	Ningbo No. 1 Hospital
Contact
Status	Completed
Phase	N/A
Start date	October 7, 2022
Completion date	July 1, 2023

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05666479` - CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
Completed	`NCT05647083` - The Effect of Massage on Diabetic Parameters	N/A
Active, not recruiting	`NCT05661799` - Persistence of Physical Activity in People With Type 2 Diabetes Over Time.	N/A
Completed	`NCT03686722` - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin	Phase 1
Completed	`NCT02836704` - Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)	Phase 4
Completed	`NCT01819129` - Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes	Phase 3
Completed	`NCT04562714` - Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy	N/A
Completed	`NCT02009488` - Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM)	Phase 1
Completed	`NCT05896319` - Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2	N/A
Recruiting	`NCT05598203` - Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes	N/A
Completed	`NCT05046873` - A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People	Phase 1
Completed	`NCT04030091` - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus	Phase 4
Terminated	`NCT04090242` - Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes	N/A
Completed	`NCT03620357` - Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D)	N/A
Completed	`NCT03604224` - A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
Completed	`NCT01696266` - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Completed	`NCT03620890` - Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy	Phase 4
Withdrawn	`NCT05473286` - A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
Not yet recruiting	`NCT05029804` - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes	N/A
Completed	`NCT04531631` - Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes	Phase 2