The Effects of a Novel Lifestyle Intervention Program on Insulin Sensitivity in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

— CH_DDZ  

Official title:

The Effects of a Novel Real Food Based Digital Education-assisted Lifestyle Intervention Program on Metabolism in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04509245
• Other study ID #: Changing_Health_DDZ
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: June 2023
• Source: German Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Moderate weight reduction by a moderately hypocaloric very-low-fat diet resulted in normalization of fasting hyperglycemia and reversal of hepatic insulin resistance in patients with poorly controlled type 2 diabetes. The Diabetes Remission Clinical Trial (DiRECT) revealed that utilizing a total diet replacement by a low-energy formula diet for 3 months led to a 15 kg or more weight loss in 24% participants and diabetes remission 46% of the participants. To date it remains unknown whether similar results can be achieved with a natural, non-formula based diet in connection with an educative smartphone application and telephone coaching

Description:

24 patients with type 2 diabetes from the German Diabetes Study (GDS) with less than 4 years disease duration and not receiving insulin were included in this study. Before the start of the intervention, participants documented their dietary intake by recording a food diary. During the 12-week intervention participants were asked to adhere to a real food-based low-calorie diet supported by an app-guided digital education program as well as a low-calorie recipe book and received weekly coaching calls by nutritionists. Patients were instructed to adhere to a balanced low calorie diet during the intervention. Nutritionists provided structured behavior change focusing on dietary advice, adherence to logging dietary intake and tracking weight. At first visit, patients installed the Changing Health App (Changing Health, Newcastle, UK) and completed an app-based digital education program. This program focused on type 2 diabetes education and behavioral change in combination with weight tracking and dietary monitoring. Patients used the app throughout the study and adherence was monitored via logins. Comprehensive testing before and after the intervention comprised a mixed-meal tolerance test and liver fat.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 1, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 65 years

• Existing diagnosis of type 2 diabetes

• Individuals who use a smartphone or PC to install the app

• Individuals who are able to communicate in German

Exclusion Criteria:

• Physical disability that leads to a significant lack of mobility (wheelchair, walking aid, walking stick, cane or crutches)

• Insulin therapy

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Fatty Liver
• Fatty Liver, Nonalcoholic
• Non-alcoholic Fatty Liver Disease
• Type 2 Diabetes

Intervention

Behavioral:
• Low-calorie diet supported by an app-guided digital education program, nutritional coaching calls via phone
During the 12-week intervention participants were asked to adhere to a real food-based low-calorie diet supported by an app-guided digital education program as well as a low-calorie recipe book and received weekly coaching calls by nutritionists

Locations

Country	Name	City	State
Germany	DDZ (Deutsches Diabetes Zentrum)	Düsseldorf	NRW

Sponsors (1)

Lead Sponsor	Collaborator
German Diabetes Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in insulin sensitivity	Change in insulin sensitivity can be estimated via a mixed-meal tolerance test, a standardized liquid meal consumed by the participants	Change in insulin sensitivity after 12 weeks of intervention
Secondary	Change in öiver fat	Change in liver fat content was estimated from 1-Proton-Magnetic Resonance Spectroscopy in a human scanner	Change in liver fat after 12 weeks of intervention