Last reviewed · How we verify
NCT04509245: CH_DDZ
The Effects of a Novel Lifestyle Intervention Program on Insulin Sensitivity in Type 2 Diabetes
NA trial testing Low-calorie diet supported by an app-guided digital education program, nutritional coaching calls via phone in Type 2 Diabetes in 24 participants. Completed in 1 December 2019.
31 July 2019
Quick facts
| Lead sponsor | German Diabetes Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 24 |
| Start date | 1 October 2018 |
| Primary completion | 31 July 2019 |
| Estimated completion | 1 December 2019 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Low-calorie diet supported by an app-guided digital education program, nutritional coaching calls via phone
Conditions studied
- Type 2 Diabetes — all drugs for Type 2 Diabetes →
- Fatty Liver, Nonalcoholic — all drugs for Fatty Liver, Nonalcoholic →
Sponsor
German Diabetes Center — full company profile →
Who can join
Adults 18 to 65, any sex, with Type 2 Diabetes or Fatty Liver, Nonalcoholic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Improving insulin sensitivity, liver steatosis and fibrosis in type 2 diabetes by a food-based digital education-assisted lifestyle intervention program: a feasibility study.
Zaharia OP, Kupriyanova Y, Karusheva Y, Markgraf DF, et al · · 2021 · cited 8× · PMID 33839905 · DOI 10.1007/s00394-021-02521-3
Verify or expand the search:
- PubMed search for NCT04509245
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Type 2 Diabetes
Currently open trials in the same condition.
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- NCT07254689 — The Food for Health Study · NA · recruiting
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Other German Diabetes Center trials
Trials by the same sponsor.
- NCT06193668 — Overfeeding Induced Fat-tissue Stimulation · NA · recruiting
- NCT04219215 — Acute Hyperbaric Oxygen Treatment Increases Hepatic Insulin Sensitivity and Muscle Reactive Oxygen Species in T2D · NA · completed
- NCT04222231 — RESIST! Blood-flow Restriction Resistance Training for Improving Insulin Sensitivity in Type 2 Diabetes · NA · unknown
- NCT04088851 — "Hepatic Substrate Flux Rates in Type 2 Diabetes" · NA · active not recruiting
- NCT05046483 — Metabolic Phenotyping and Follow-Up of Patients With and Without Diabetes After New Onset of STEMI · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04509245 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by German Diabetes Center
- Last refreshed: 5 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04509245.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing