Last updated: July 19, 2022
Sponsor: Ancora Health B.V.
Overall Status: Active - Not Recruiting
Phase
N/A
Condition
Diabetes Mellitus, Type 2
Diabetes Prevention
Diabetes And Hypertension
Treatment
N/AClinical Study ID
NCT05346614
NL77688.056.21
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 fordiabetes
Exclusion
Exclusion Criteria:
- 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 pulmonarydisease (Gold III or IV), bariatric surgery, heart failure (classes 2-4) kidneyfailure, or another medically determined end-stage organ failure
- Substance abuse
- Learning difficulties limiting the participation in a digital health intervention andor 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 havinggiven birth within the previous nine months
- Hospital admission for depression
- Major psychiatric disorder (e.g., schizophrenia, bipolar disorder) or use ofantipsychotic 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 previoussix 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-melanomaskin 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 digitalcontent
- Non-English or Non-Dutch speaking
- Excessive alcohol intake (acute or chronic) defined as the average consumption ofthree or more alcohol-containing beverages daily or consumption of more than 14alcoholic beverages per week
- Cholelithiasis or biliary dysfunction
- Use of an insulin pump
- Participation in diabetes therapy within the preceding three years; participation inconcurrent 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-1or >34.2 µmol·L-1, Albumin < 3.5 g·dL-1 or <35 g·L-1)
Study Design
Total Participants: 410
Study Start date:
October 01, 2022
Estimated Completion Date:
March 01, 2025
Study Description
Connect with a study center
St. Anna Ziekenhuis
Eindhoven, Limburg
NetherlandsSite Not Available
Center Medische Kwartier Eindhoven
Eindhoven, Noord Brabant 5611 NV
NetherlandsSite Not Available
Haga Ziekenhuis
Den Haag, Zuid Holland 2545 AA
NetherlandsSite Not Available
Huisartsenpraktijk Zonneoord
Den Haag, Zuid Holland 2544 KM
NetherlandsSite Not Available

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