Clinical trial NCT04509245: The Effects of a Novel Lifestyle Intervention Program on Insulin Sensitivity in Type 2 Diabetes
Official title: The Effects of a Novel Real Food Based Digital Education-assisted Lifestyle Intervention Program on Metabolism in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Fatty Liver, Nonalcoholic
Lead sponsor: German Diabetes Center
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Change in insulin sensitivity
timeFrame: Change in insulin sensitivity after 12 weeks of intervention
Secondary outcomes:
measure: Change in öiver fat
timeFrame: Change in liver fat after 12 weeks of intervention
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: DDZ (Deutsches Diabetes Zentrum)
state: NRW
Study officials:
affiliation: German Diabetes Center
name: Michael Roden, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.