NCT04509245

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed
Last Updated

June 5, 2023

Status Verified

June 1, 2023

Enrollment Period

10 months

First QC Date

August 6, 2020

Last Update Submit

June 2, 2023

Conditions

Type 2 DiabetesFatty Liver, Nonalcoholic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in öiver fat

    Change in liver fat after 12 weeks of intervention

Study Arms (1)

Effects of a digitally assisted lifestyle intervention

EXPERIMENTAL

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

Interventions

Low-calorie diet supported by an app-guided digital education program, nutritional coaching calls via phoneBEHAVIORAL

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

Effects of a digitally assisted lifestyle intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Physical disability that leads to a significant lack of mobility (wheelchair, walking aid, walking stick, cane or crutches)
  • Insulin therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DDZ (Deutsches Diabetes Zentrum)

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Related Publications (1)

  • 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.

    PMID: 33839905DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesFatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Michael Roden, MD

    German Diabetes Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2020

First Posted

August 12, 2020

Study Start

October 1, 2018

Primary Completion

July 31, 2019

Study Completion

December 1, 2019

Last Updated

June 5, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)