Status:
UNKNOWN
Digital, Blended Lifestyle Intervention for Type 2 Diabetes Remission
Lead Sponsor:
Ancora Health B.V.
Collaborating Sponsors:
University of Groningen
Universiteit Leiden
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
410 Dutch type 2 diabetes patients will be randomized using a 5:1 ratio to intervention group versus control, to a lifestyle intervention program given via a mobile application and digital platform. A...
Detailed Description
Patients will partake in a 24-week intervention followed by a two-year follow-up period. The intervention will consist of diabetic phenotyping (diabetyping), and a personalized app-based lifestyle int...
Eligibility Criteria
Inclusion
- Diabetes: Diagnosis of T2DM without physician defined end-organ failure
- BMI: 25 to 45 kg/m²
- Age: 18 to 75 years
- Most recent HbA1c value should be greater than 6.0% (\>43 mmol/mol); if less than 6.5% (\<48 mmol/mol), individuals should still be receiving anti-diabetic medication
- Tech-savvy (patients are required to be able to fully use smartphone or tablet)
- Display interest and motivation to enroll in a digital, lifestyle intervention for diabetes
Exclusion
- Weight loss of more than five kg or greater than 10% within the past six months
- Serious co-morbidities, for example, a severe form of chronic obstructive pulmonary disease (Gold III or IV), bariatric surgery, heart failure (classes 2-4) kidney failure, or another medically determined end-stage organ failure
- Substance abuse
- Learning difficulties limiting the participation in a digital health intervention and or limiting the comprehension of trial goals or coaching curriculum.
- Current treatment with anti-obesity drugs
- Pregnancy, consideration of pregnancy within the study period, lactation or having given birth within the previous nine months
- Hospital admission for depression
- Major psychiatric disorder (e.g., schizophrenia, bipolar disorder) or use of antipsychotic drugs.
- Currently uncontrolled or eating disorder or purging behavior
- Type 1 diabetes
- History of keto-acidosis
- Myocardial infarction, stroke, angina, or coronary insufficiency within the previous six months
- Diabetic retinopathy requiring treatment
- Creatinine \> 2.0 mg·dL-1 or \> 152.5 µmol·L-1
- Urinary albumin \> 1 g·dL-1 or \> 10 g·L-1
- Cancer requiring treatment in the past five years, with the exception of non-melanoma skin cancer
- Chronic infectious disease requiring ongoing treatment
- Other chronic diseases or conditions likely to limit lifespan to less than six years
- Severe visual impairment or other impairment preventing interaction with digital content
- Non-English or Non-Dutch speaking
- Excessive alcohol intake (acute or chronic) defined as the average consumption of three or more alcohol-containing beverages daily or consumption of more than 14 alcoholic beverages per week
- Cholelithiasis or biliary dysfunction
- Use of an insulin pump
- Participation in diabetes therapy within the preceding three years; participation in concurrent weight management or interventional research protocol,
- Untreated thyroid disease,
- Requirement of a prescribed medical diet
- A recent on-record estimated glomerular filtration rate of less than 30 mL/min per 1.732 m²
- Incapacitated patients, and thus unable to fully participate in the trial.
- uncontrolled blood pressure (SBP \> 170 mmHg and/or DBP \> 100 mmHg)
- For nutritional ketosis specifically: impaired hepatic function (Bilirubin \>2 mg·dL-1 or \>34.2 µmol·L-1, Albumin \< 3.5 g·dL-1 or \<35 g·L-1)
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT05346614
Start Date
October 1 2022
End Date
March 1 2025
Last Update
July 20 2022
Active Locations (4)
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1
St. Anna Ziekenhuis
Eindhoven, Limburg, Netherlands
2
Center Medische Kwartier Eindhoven
Eindhoven, North Brabant, Netherlands, 5611 NV
3
Huisartsenpraktijk Zonneoord
The Hague, South Holland, Netherlands, 2544 KM
4
Haga Ziekenhuis
The Hague, South Holland, Netherlands, 2545 AA