NCT02968498已完成不适用
Blood Glucose Response After Oral Intake of Lactulose in Healthy Volunteers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Capillary blood glucose levels as incremental area under the curve (iAUC) above baseline (iAUC(0-180min))
研究概览
简要总结
Prospective, open, mono-center, randomized, two part study with 4-way cross-over design in each study part.
The objective of the study is to investigate blood glucose levels after oral intake of defined amounts of lactulose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Age: 18-65 years
- •Approx. 3-5 bowel movements per week
- •Caucasian
- •Availability and presence in the trial unit for approx. 4 hours/ week for 4 times in a row with approx. 1 week of washout in between
- •Signed informed consent form
排除标准
- •Known (family) history of diabetes mellitus or use of anti-hyperglycaemic drugs or Insulin
- •Clinically relevant renal or hepatic disease, liver enzymes > 10% above reference range
- •Fasting blood glucose > 100 mg/dL or HbA1c outside of reference range
- •Total cholesterol > 250 mg/dL or triglycerides > 150 mg/dL
- •Haemoglobin < 11 g/dL (women); < 12.5 g/dL (men)
- •BMI < 19 kg/m² and ≥ 30 kg/m²
- •Intentional and unintentional weight loss > 5% in the previous 6 months
- •Major medical or surgical event requiring hospitalization within the previous 3 months
- •Presence of disease or drug(s) influencing digestion and absorption of nutrients or bowel habits
- •Intake of medications known to affect glucose tolerance, e.g., steroids, protease inhibitors or antipsychotics (stable doses of e.g., oral contraceptives, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable)
- •Chronic intake of substances affecting blood coagulation (e.g. acetylic acid, anticoagulants, diuretics, thiazides), which in the investigator's opinion would impact volunteer safety
- •Hereditary problems of galactose or fructose intolerance, lactase deficiency or glucose-galactose malabsorption
- •Suspicion of drug abuse
- •Abuse of alcoholic drinks, defined as an average daily intake of more than one litre of beer per day or equivalent amount of alcohol in other beverages
- •Pregnant or breast feeding women
- •Known or suspected allergy to any component of the investigational product(s)
- •Known HIV-infection
- •Known acute or chronic hepatitis B and C infection
- •Blood donation within 4 weeks prior to visit 1 or during the study
- •Volunteer unable to co-operate adequately
- •Participation in a clinical trial with an investigational product within one month before start of study
结局指标
主要结局
Capillary blood glucose levels as incremental area under the curve (iAUC) above baseline (iAUC(0-180min))
时间窗: 0-180 min
次要结局
- Total area under curve from 0 to 180 min for blood glucose concentration (AUC(0-180min))(0-180 min)
- Maximum blood glucose concentration (Cmax)(0-180 min)
- Relative maximum increase of blood glucose concentration(Max_increase rel)(0-180 min)
- Adverse events (AEs)(After screening till study day 22 (+24 hours))
- Gastrointestinal tolerability (assessed by subject's questionnaire)(24 hours post-dose)
- Baseline corrected area under curve from 0 to 180 min for blood glucose concentration (AUCbase_c(0-180min))(0-180 min)
- Maximum increase of blood glucose concentration (Max_increase)(0-180 min)
- Time to reach maximum blood glucose concentration (Tmax)(0-180 min)
- First time to reach baseline again after increase or decrease in blood glucose (Tbaseline)(0-180 min)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
4 期
Blood Glucose Response After Oral Intake of Lactulose in Mildly Constipated Patients With Diabetes Mellitus Type 2Diabetes Mellitus, Type 2NCT03666546Fresenius Kabi24
进行中（未招募）
1 期
Blutzuckerreaktion nach der oralen Einnahme von Laktulose (Laevolac®) bei leicht verstopften Patienten mit Typ 2 Diabetes mellitusEUCTR2018-002359-14-ATFresenius Kabi Deutschland GmbH24
已完成
不适用
Effect of oral lactulose on clinical and immunohistochemical parameters in patients with inflammatory bowel disease: a prospective, randomised and controlled pilot studyISRCTN92101486Solvay Pharmaceuticals GmbH (Germany)70
已完成
1 期
Determination of glycemic response to the consumption of two specialized formulas for glycemic controlHyperglycemiaRBR-6zw2fnbProdiet Medical Nutrition
尚未招募
不适用
Does Co-administration of Lactate to an Oral Glucose Tolerance Test Lower the Glucose Response?Metabolic SyndromeInsulin ResistancePreDiabetesNCT06265337University of Aarhus12