Type 2 Diabetes Clinical Trial
— CH_DDZOfficial title:
The Effects of a Novel Real Food Based Digital Education-assisted Lifestyle Intervention Program on Metabolism in Type 2 Diabetes
Verified date | June 2023 |
Source | German Diabetes Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
Germany | DDZ (Deutsches Diabetes Zentrum) | Düsseldorf | NRW |
Lead Sponsor | Collaborator |
---|---|
German Diabetes Center |
Germany,
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 |
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