Fatty Liver, Nonalcoholic, Type 2 Diabetes
Conditions
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.
Interventions
BEHAVIORALLow-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
Sponsors
German Diabetes Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in insulin sensitivity | Change in insulin sensitivity after 12 weeks of intervention | Change in insulin sensitivity can be estimated via a mixed-meal tolerance test, a standardized liquid meal consumed by the participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in öiver fat | Change in liver fat after 12 weeks of intervention | Change in liver fat content was estimated from 1-Proton-Magnetic Resonance Spectroscopy in a human scanner |
Countries
Germany
Outcome results
None listed