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The Effects of a Novel Lifestyle Intervention Program on Insulin Sensitivity in Type 2 Diabetes (CH_DDZ)

Primary Purpose

Type 2 Diabetes, Fatty Liver, Nonalcoholic

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Low-calorie diet supported by an app-guided digital education program, nutritional coaching calls via phone
Sponsored by
German Diabetes Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • DDZ (Deutsches Diabetes Zentrum)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Effects of a digitally assisted lifestyle intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in öiver fat
Change in liver fat content was estimated from 1-Proton-Magnetic Resonance Spectroscopy in a human scanner

Full Information

First Posted
August 6, 2020
Last Updated
June 2, 2023
Sponsor
German Diabetes Center
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1. Study Identification

Unique Protocol Identification Number
NCT04509245
Brief Title
The Effects of a Novel Lifestyle Intervention Program on Insulin Sensitivity in Type 2 Diabetes
Acronym
CH_DDZ
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
German Diabetes Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Fatty Liver, Nonalcoholic

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Effects of a digitally assisted lifestyle intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Low-calorie diet supported by an app-guided digital education program, nutritional coaching calls via phone
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in insulin sensitivity
Description
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
Secondary Outcome Measure Information:
Title
Change in öiver fat
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Roden, MD
Organizational Affiliation
German Diabetes Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
DDZ (Deutsches Diabetes Zentrum)
City
Düsseldorf
State/Province
NRW
ZIP/Postal Code
40225
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33839905
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.
Results Reference
derived

Learn more about this trial

The Effects of a Novel Lifestyle Intervention Program on Insulin Sensitivity in Type 2 Diabetes

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