NCT03289494已完成不适用
A Pilot Randomized Controlled Trial Evaluating the Effect of Two Diets With Different Starch Digestibility Profiles on Daily Glycemic Profile Measured by Continuous Glucose Monitoring System (CGMS), in Type 2 Diabetic Patients
Mondelēz International, Inc.2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2017年8月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Mean postprandial incremental Area Under the Curve (iAUC), measured by CGMS
研究概览
简要总结
The study is a randomized cross-over pilot study. The research hypothesis is that the diet high in SDS content (H-SDS) will lower the daylong glycemic response and improve the glycemic control in patients with type 2 diabetes (T2D) compared to the diet low in SDS content (L-SDS).
详细描述
The study is a randomized cross-over pilot study. The research hypothesis is that the diet high in SDS content (H-SDS) will lower the daylong glycemic response and improve the glycemic control in patients with type 2 diabetes (T2D) compared to the diet low in SDS content (L-SDS).
8 patients with type 2 diabetic patients will be recruited.
Subjets will have 5 visits:
The selection visit (V1) is required to check whether the patients fulfill inclusion and exclusion criteria for the study.
The visit V2 will include randomization, medical check-up and a dietary interview (LogBook supply with explanations for filling and dietary advice cards for the 1st week of diet). The nurse will insert the CGMS and the patient will receive detailed instructions on wearing the sensor and recorder. The patient will leave the research center with a glucometer, the starchy foods and cereal products adapted for its first week of diet and the associated cooking instruction sheets and menus given by the dietician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Each diet will be labelled "Diet A" or "Diet B"
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient able to understand the study information and providing written consents for his/her participation to the study
- •Male or female
- •Patient undergoing medical examination during the selection visit
- •Patient aged between 18 and 75 years old (bounds included)
- •T2D volunteer with:
- •HbA1c between 6,5% and 8,5%
- •Bi-therapy associating metformin and sitagliptin at stable dose for at least 1 month
- •T2D volunteer without insulin therapy or GLP-1 analogues
- •Patient with BMI ranging between 22 and 37 kg/m2 (bounds included)
- •Patient with stable body weight over the past three months (+/- 5 % of body weight)
- •Patient accepting to change its diet for two weeks
- •Patient not suffering from intolerance or allergy
- •Patient regularly consuming products proposed in the study
- •Patient regularly consuming 3 main meals per day
- •Sedentary behavior or stable regular physical activity during the study
- •Patient not presenting any disease during the medical examination / interview which could interfere with the results of the study according to the investigator
- •Patient covered by health assurance
排除标准
- •General criteria:
- •Patient under legal protection measure
- •Patient deprived of liberty by a court or an administrative decision
- •Patient currently participating in another study or being in the exclusion period of another study
- •Volunteer that exceed the financial compensation allowed per year for participating in research programs
- •Biological criteria:
- •Gamma-GT > 2.5 times above the norm (>160 UI/L)
- •ASAT > 2.5 times above the norm (>85 UI/L)
- •ALAT > 2.5 times above the norm (>137.5 UI/L)
- •Triglycerides > 4 g/L
- •LDL-cholesterol > 1.90 g/L
- •CRP > 15 mg/L
- •Hemoglobin < 120 mg/dL
- •Other biological abnormality with clinical significant relevance according to the investigator
- •Therapeutic and medical criteria:
- •Patient with type 1 diabetes
- •T2D treatment other than metformin and sitagliptin
- •Patient with past bariatric surgery
- •Patient with medical history of endocrine diseases who may interfere with glucose metabolism according to the investigator (such as thyroid dysfunction, acromegaly, hypercorticism...)
- •Uncontrolled high blood pressure defined by Systolic blood pressure > 150 mmHg or Diastolic blood pressure > 100 mmHg
- •Evidence of any other unstable or untreated clinically significant immunological, neoplasic, endocrine, haematological, gastrointestinal, hepatic, neurological or psychiatric abnormalities or medical disease according to the investigator
- •Pregnant women or willing to become pregnant or lactating women
- •Women of childbearing age without an efficient contraceptive method according to the investigator
- •Patient under a restrictive diet or willing to lose weight
- •Patient with eating disorders (e.g. anorexia nervosa and bulimia) according to the investigator
- •Patient without stable dietary habits or with specific diet (vegetarian, vegan,...) according to the investigator
- •Patient who smokes
- •Patient regularly consuming more than 20 g/day of alcohol. Consumption of more than 3 alcoholic beverages per day is recognized as excessive. An alcoholic beverage is: 30 mL of spirituous, 120 mL of wine or 330 mL of beer
- •Patient regularly consuming recreational drugs
- •Patient consuming in the two previous months regularly corticoids, anorectics, adrenergic drugs, beta-blocking drugs, antiplatelet agent (like aspirin) or other drugs or supplement that should impact glucose metabolism (other than metformin or DPP4 inhibitor) in the investigator's opinion
- •Adhesive plaster skin allergy
结局指标
主要结局
Mean postprandial incremental Area Under the Curve (iAUC), measured by CGMS
时间窗: minimum 2h to maximum 6h postprandial periods and average value of minimum 3 days to a maximum of 6 days of CGMS record
The iAUC will be calculated using the trapezoid rule. The iAUC includes all area below the curve and above the fasting concentration, with any area beneath fasting being ignored.
次要结局
- Glycemic profile parameters: total AUC(minimum 3 days to a maximum of 6 days of CGMS record)
- Glycemic profile parameters: Standard Deviation (SD) from CGMS glycaemia(minimum 3 days to a maximum of 6 days of CGMS record)
- Glycemic profile parameters: MODDs(minimum 3 days to a maximum of 6 days of CGMS record)
- Dietary intake evaluation(After 1 week intervention diet)
- Charaterisation of acceptability to H-SDS diet in free living conditions(After 1 week intervention diet)
- Glycemic profile parameters: maximum glycaemia(minimum 3 days to a maximum of 6 days of CGMS record)
- Glycemic profile parameters: mean glycemic value(minimum 3 days to a maximum of 6 days of CGMS record)
- Glycemic profile parameters: kinetics(minimum 3 days to a maximum of 6 days of CGMS record)
- Compliance parameters: mean SDS ingestion(maximum of 6 days of LogBook record)
- Dietary record evaluation(After 1 week intervention diet)
- Glycemic profile parameters: Coefficient of Variation (CV) from CGMS glycaemia(minimum 3 days to a maximum of 6 days of CGMS record)
- Glycemic profile parameters: MAGE(minimum 3 days to a maximum of 6 days of CGMS record)
- Glycemic profile parameters: MIME(minimum 3 days to a maximum of 6 days of CGMS record)
- Glycemic profile parameters: Time in Range(minimum 3 days to a maximum of 6 days of CGMS record)
- Glycemic profile parameters: CONGA(minimum 3 days to a maximum of 6 days of CGMS record)
- Glycemic profile parameters: hyperglycemia durations(minimum 3 days to a maximum of 6 days of CGMS record)
- Glycemic profile parameters: hypoglycemia durations(minimum 3 days to a maximum of 6 days of CGMS record)
- Glycemic profile parameters: incremental AUC(minimum 3 days to a maximum of 6 days of CGMS record)
- Glycemic profile parameters: Minimum glycaemia(minimum 3 days to a maximum of 6 days of CGMS record)
- Glycemic profile parameters: ADRR(minimum 3 days to a maximum of 6 days of CGMS record)
研究者
研究点 (2)
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