NCT04758858撤回不适用
Carbohydrates Under Target for Type 1 Diabetes Management
Institut de Recherches Cliniques de Montreal2 个研究点 分布在 1 个国家开始时间: 2021年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Percentage of time-in-target (range of 4-10 mmol/L)
研究概览
简要总结
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% Lipid) diets are being advocated among people living with diabetes given their almost immediate favorable impact on post-prandial blood glucose levels and on hemoglobin A1c that have been reported by users. Adoption of these diets are met with reluctance by healthcare professionals due to the lack of information on their safety. Concerns include the impact on hypoglycemia frequency and glucagon response to hypoglycemia, diabetic ketoacidosis, lipid profile, liver function insulin dose adjustments when adopting them in the context of type 1 diabetes (T1D). Through a series of interviews, people with diabetes following a VLCHF reported that the lack of support from HCPs often leads to hiding the fact that they have adopted a VLCHF diet. This is an important source of concern that can lead to additional safety issues.
The goal is to fill an important knowledge gap about the effectiveness, benefits and risks of low CHO and VLCHF diets for people with T1D. The primary objective is to compare the percentage of TIR of adults with T1D following a low-CHO diet or a VLCHF diet versus a control diet for 12 weeks. The secondary objectives are (1) to evaluate efficacy of glucagon in correcting hypoglycemia in the context of restricted carbohydrates intakes; (2) to evaluate changes in HbA1c at 12 weeks and glucose fluctuations and % of time in hypoglycemia at 6 weeks and 12 weeks of control diet, low-CHO diet or VLCHF diet; (3) to compare key cardiometabolic risk factors (body composition, blood lipids, blood pressure and liver inflammatory markers and function) at 6 weeks and 12 weeks of control diet, low-CHO diet or VLCHF diet; (4) to evaluate the effect of restrictive CHO diets (low-CHO and VLCHF) on the composition of the intestinal microbiota (optional).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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!
排除标准
- •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®)
结局指标
主要结局
Percentage of time-in-target (range of 4-10 mmol/L)
时间窗: From enrollment to end of study, total of 14 weeks
Using continuous glucose monitoring (FreeStyle Libre)
次要结局
- Coefficient of glucose variation (%)(From enrollment to end of study, total of 14 weeks)
- Glycated hemoglobin (HbA1c)(During blood test : At baseline (day 1), before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14))
- Post-prandial blood glucose(From beginning (week 3) to end (week 14) of diet intervention)
- Insulin daily dose(From enrollment to end of study, total of 14 weeks)
- Waist circumference (cm)(At baseline (day 1), before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14))
- Lipids composition(Three days during the first 2 weeks (3-day food journal) and from beginning (week 3) to end (week 14) of diet intervention)
- Self-reported symptoms(From enrollment to end of study, total of 14 weeks)
- Time to resolve an induced hypoglycemia (>4 mmol/L)(After administration of subcutaneous insulin; At beginning (week 3) and end (week 14) of the diet intervention, each test lasts approximately 5 hours)
- Peak plasma glucose level two hours after glucagon administration(After administration of glucagon; At beginning (week 3) and end (week 14) of the diet intervention, each test lasts approximately 5 hours)
- Fructosamine(During blood test : At baseline (day 1), before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14))
- Fasting blood glucose(From beginning (week 3) to end (week 14) of diet intervention)
- Insulin-to-CHO ratio(From enrollment to end of study, total of 14 weeks)
- Weight (kg)(At baseline (day 1), before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14))
- Total lean mass (kg)(During DEXA-scan : At beginning (week 3) and end (week 14) of the diet intervention, each test lasts approximately 15 minutes)
- Gamma-glutamyl transpeptidase(During blood test : At baseline (day 1), before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14))
- Albumin(During blood test : At baseline (day 1), before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14))
- High sensitivity CRP(During blood test : At baseline (day 1), before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14))
- Respiratory quotient(During indirect calorimetry test : At beginning (week 3) and end (week 14) of the diet intervention, each test lasts approximately 30 minutes)
- Liver proton density fat fraction(During MRI : At beginning (week 3) and end (week 14) of the diet intervention, each test lasts approximately 30 minutes)
- Total liver volume(During MRI : At beginning (week 3) and end (week 14) of the diet intervention, each test lasts approximately 30 minutes)
- Visual Analog Score for nausea (none to intolerable)(Before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14))
- Visual Analog Score for diet satisfaction (not appreciated to very appreciated)(Before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14))
- Severity of hypoglycemia episodes (mild or severe)(From enrollment to end of study, total of 14 weeks)
- Capillary ketone body levels(From beginning (week 3) to end (week 14) of diet intervention)
- Daily caloric intake (kcal/day)(Three days during the first 2 weeks (3-day food journal) and from beginning (week 3) to end (week 14) of diet intervention)
- Total fat mass (%)(During DEXA-scan : At beginning (week 3) and end (week 14) of the diet intervention, each test lasts approximately 15 minutes)
- Truncal fat mass (%)(During DEXA-scan : At beginning (week 3) and end (week 14) of the diet intervention, each test lasts approximately 15 minutes)
- Truncal lean mass (%)(During DEXA-scan : At beginning (week 3) and end (week 14) of the diet intervention, each test lasts approximately 15 minutes)
- Mean liver PDFF(During MRI : At beginning (week 3) and end (week 14) of the diet intervention, each test lasts approximately 30 minutes)
- Total liver fat index(During MRI : At beginning (week 3) and end (week 14) of the diet intervention, each test lasts approximately 30 minutes)
- Well-being score(Before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14))
- Visual Analog Score for hunger (none to intolerable)(Before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14))
- Apo-A1(During blood test : At baseline (day 1), before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14))
- Total lean mass (%)(During DEXA-scan : At beginning (week 3) and end (week 14) of the diet intervention, each test lasts approximately 15 minutes)
- Truncal fat mass (kg)(During DEXA-scan : At beginning (week 3) and end (week 14) of the diet intervention, each test lasts approximately 15 minutes)
- Beta diversity (optional)(Before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14))
- Carbohydrates composition(Three days during the first 2 weeks (3-day food journal) and from beginning (week 3) to end (week 14) of diet intervention)
- Basal insulin doses(From enrollment to end of study, total of 14 weeks)
- Percentage of time spent in hypoglycemia ranges < 4 mmol/L(From enrollment to end of study, total of 14 weeks)
- Percentage of time spent in significant hypoglycemia ranges < 3 mmol/L(From enrollment to end of study, total of 14 weeks)
- Height (cm)(At baseline (day 1), before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14))
- Total cholesterol(During blood test : At baseline (day 1), before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14))
- HDL-cholesterol(During blood test : At baseline (day 1), before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14))
- LDL-cholesterol(During blood test : At baseline (day 1), before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14))
- Triglycerides(During blood test : At baseline (day 1), before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14))
- Truncal lean mass (kg)(During DEXA-scan : At beginning (week 3) and end (week 14) of the diet intervention, each test lasts approximately 15 minutes)
- Systolic blood pressure (mmHg)(At baseline (day 1), before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14))
- Aminotransferases(During blood test : At baseline (day 1), before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14))
- Bilirubin(During blood test : At baseline (day 1), before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14))
- Apo-B(During blood test : At baseline (day 1), before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14))
- Total fat mass (kg)(During DEXA-scan : At beginning (week 3) and end (week 14) of the diet intervention, each test lasts approximately 15 minutes)
- Diastolic blood pressure (mmHg)(At baseline (day 1), before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14))
- Alkaline phosphatase(During blood test : At baseline (day 1), before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14))
- Resting metabolic rate (kcal/day)(During indirect calorimetry test : At beginning (week 3) and end (week 14) of the diet intervention, each test lasts approximately 30 minutes)
- Visual Analog Score for difficulty for meal preparation (no difficulty to extreme difficulty)(Before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14))
- Proteins composition(Three days during the first 2 weeks (3-day food journal) and from beginning (week 3) to end (week 14) of diet intervention)
- Visual Analog Score for fatigue (none to intolerable)(Before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14))
- Visual Analog Score for abdominal cramp/pain (none to intolerable)(Before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14))
- Visual Analog Score for headache (none to intolerable)(Before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14))
- Visual Analog Score for difficulty to follow the diet (no difficulty to extreme difficulty)(Before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14))
- Steps/day (physical activity)(From enrollment to end of study, total of 14 weeks)
- Number hypoglycemia episodes(From enrollment to end of study, total of 14 weeks)
- Alpha diversity (optional)(Before diet intervention (week 3), halfway the diet intervention (week 8) and at the end of the diet intervention (week 14))
研究者
Rémi Rabasa-Lhoret
Full professor
Institut de Recherches Cliniques de Montreal
研究点 (2)
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