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

NCT ID: NCT04509245

Last Updated: 2023-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-12-01

Brief 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

Detailed 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.

Conditions

Type 2 Diabetes; Fatty Liver, Nonalcoholic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Effects of a digitally assisted lifestyle intervention

Testing the effects of a low-calorie diet in connection with app-based digital education and behavioral change program on glucose metabolism and disease management.

Group Type: EXPERIMENTAL

Low-calorie diet supported by an app-guided digital education program, nutritional coaching calls via phone

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Diabetes Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Roden, MD

Role: PRINCIPAL_INVESTIGATOR

German Diabetes Center

Locations

DDZ (Deutsches Diabetes Zentrum)

Düsseldorf, North Rhine-Westphalia, Germany

Countries

Germany

References

Zaharia OP, Kupriyanova Y, Karusheva Y, Markgraf DF, Kantartzis K, Birkenfeld AL, Trenell M, Sahasranaman A, Cheyette C, Kossler T, Bodis K, Burkart V, Hwang JH, Roden M, Szendroedi J, Pesta DH. Improving insulin sensitivity, liver steatosis and fibrosis in type 2 diabetes by a food-based digital education-assisted lifestyle intervention program: a feasibility study. Eur J Nutr. 2021 Oct;60(7):3811-3818. doi: 10.1007/s00394-021-02521-3. Epub 2021 Apr 11.

Reference Type: DERIVED

PMID: 33839905 (View on PubMed)

Other Identifiers

Changing_Health_DDZ

Identifier Type: -

Identifier Source: org_study_id