Status:
WITHDRAWN
Carbohydrates Under Target for Type 1 Diabetes Management
Lead Sponsor:
Institut de Recherches Cliniques de Montreal
Collaborating Sponsors:
McGill University
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Recently, there has been an increased interest in limiting carbohydrates (CHO) intakes for improving long-term health. Low CHO (\<30% energy from CHO) and very low CHO high fat (VLCHF; 10% CHO, 75% Li...
Eligibility Criteria
Inclusion
- Men and women \> 18 years old
- Duration of T1D \> 12 months
- On intensive insulin therapy
- Own a smartphone or tablet to use two mobile applications for nutritional and physical activity tracking: Keenoa and Piezo: Achieve the Guidelines!
Exclusion
- Already following a low-CHO diet (\<30% CHO)
- Type 2 diabetes or other form of diabetes
- Known gastroparesis (clinical diagnosis)
- Advanced kidney disease (eGFR \< 50 mL/min)
- Known significant liver disease (e.g. cirrhosis, active hepatitis, liver transplantation)
- Recent (\<6 months) major cardiovascular event (e.g. myocardial infarction, cerebrovascular accident, major revascularization, etc.)
- Pregnancy (ongoing or planned in the next 6 months)
- Breastfeeding (ongoing)
- Recent severe hypoglycemia episodes (BG \<2.8 mmol/L or assistance from a third party) or ketoacidosis (\<6 weeks)
- Claustrophobia or presence of metal devices/implants in the body
- Recent (\<6 weeks) or planned (next 6 months) modification in insulin treatment
- Recent (\<6 weeks) or planned (next 6 months) modification in cardiometabolic drugs for blood pressure and/or lipids. These drugs must remain stable all along the trial
- Off label adjunct therapy with SGLT-2 inhibitors (Forxiga®, Invokana® or Jardiance®)
- Recent (\<6 weeks) or planned (next 6 months) modification of adjunct therapy (Metformin, Glumetza®, Victoza®, Trulicity® and Ozempic®)
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04758858
Start Date
March 1 2021
End Date
March 1 2023
Last Update
July 13 2021
Active Locations (1)
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1
Institut de recherches cliniques de Montréal
Montreal, Quebec, Canada, H2W 1R7