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Completed

NCT Number: NCT04509245

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

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

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Digestive System Diseases Endocrine System Diseases Fatty Liver Fatty Liver, Nonalcoholic Glucose Metabolism Disorders Liver Diseases Metabolic Diseases Non-alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

DDZ (Deutsches Diabetes Zentrum)

Düsseldorf, North Rhine-Westphalia, 40225, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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 outcomes

  1. Change in insulin sensitivity

    Time frame: Change in insulin sensitivity after 12 weeks of intervention

    Change in insulin sensitivity can be estimated via a mixed-meal tolerance test, a standardized liquid meal consumed by the participants

Secondary outcomes

  1. Change in öiver fat

    Time frame: Change in liver fat after 12 weeks of intervention

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

Sponsors and collaborators

Lead sponsor

German Diabetes Center

Other

Registry information

Official study title

The Effects of a Novel Real Food Based Digital Education-assisted Lifestyle Intervention Program on Metabolism in Type 2 Diabetes

Acronym: CH_DDZ

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 12, 2020
Registry last updated
Jun 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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