The Effects of a Novel Lifestyle Intervention Program on Insulin

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04509245
Study type	Interventional
Source	German Diabetes Center
Contact
Status	Completed
Phase	N/A
Start date	October 1, 2018
Completion date	December 1, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05219994` - Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum	N/A
Completed	`NCT04056208` - Pistachios Blood Sugar Control, Heart and Gut Health	Phase 2
Completed	`NCT02284893` - Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone	Phase 3
Completed	`NCT04274660` - Evaluation of Diabetes and WELLbeing Programme	N/A
Active, not recruiting	`NCT05887817` - Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR)	Phase 4
Active, not recruiting	`NCT05566847` - Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes	N/A
Recruiting	`NCT06007404` - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Completed	`NCT04965506` - A Study of IBI362 in Chinese Patients With Type 2 Diabetes	Phase 2
Recruiting	`NCT06115265` - Ketogenic Diet and Diabetes Demonstration Project	N/A
Active, not recruiting	`NCT03982381` - SGLT2 Inhibitor or Metformin as Standard Treatment of Early Stage Type 2 Diabetes	Phase 4
Completed	`NCT04971317` - The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages	N/A
Completed	`NCT04496154` - Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood	N/A
Completed	`NCT04023539` - Effect of Cinnamomum Zeylanicum on Glycemic Levels of Adult Patients With Type 2 Diabetes	N/A
Recruiting	`NCT05572814` - Transform: Teaching, Technology, and Teams	N/A
Enrolling by invitation	`NCT05530356` - Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
Completed	`NCT04097600` - A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets	Phase 1
Completed	`NCT03960424` - Diabetes Management Program for Hispanic/Latino	N/A
Completed	`NCT05378282` - Identification of Diabetic Nephropathy Biomarkers Through Transcriptomics
Recruiting	`NCT06010004` - A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes	Phase 3
Completed	`NCT03653091` - Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms