An interventional study of Low-calorie diet supported by an app-guided digital education program, nutritional coaching calls via phone in Type 2 Diabetes and Fatty Liver, Nonalcoholic, sponsored by German Diabetes Center. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-06-05.
Sponsored by German Diabetes Center · Not applicable, Interventional, and Basic science
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
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.
1,451 studies on the registry are indexed under Fatty Liver; 292 are open to participants now.
This study's enrollment of 24 is below the median of 60 across 1,003 interventional studies indexed under Fatty Liver.
Browse Fatty Liver studies →German Diabetes Center is the lead sponsor of 27 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
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.
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
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
Time frame: Change in insulin sensitivity after 12 weeks of intervention
Change in öiver fat
Change in liver fat content was estimated from 1-Proton-Magnetic Resonance Spectroscopy in a human scanner
Time frame: Change in liver fat after 12 weeks of intervention
Plan to share: No
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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German Diabetes Center