NCT03666546已完成4 期
Blood Glucose Response After Oral Intake of Lactulose (Laevolac®) in Mildly Constipated Patients With Diabetes Mellitus Type 2
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Capillary blood glucose levels as baseline corrected AUC: AUCbaseline_c (0-180 minutes) [Baseline corrected area under curve from 0 to 180 minutes for blood glucose concentration (= Area under curve from 0 to 180 minutes minus baseline*180 minutes)]
研究概览
简要总结
The objective of the study is to investigate whether lactulose, given orally as powder or liquid, increases blood glucose levels in patients with diabetes mellitus type 2. The dose of lactulose given in the study is normally used for treatment of constipation.
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
- Double (Participant, Investigator)
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
- •Patients with non-insulin requiring diabetes mellitus type 2 treated with diet and oral antidiabetics and/or Glucagon-like Peptide 1 receptor agonists
- •Age: 18-75 years
- •Female and male
- •HbA1c ≤ 7.5 %
- •Stable treatment, i.e. no change in diabetes mellitus related medication within the last 3 months
- •Mild functional constipation according to modified Rome IV criteria fulfilled for the last 3 months with symptom onset at least 6 months before study start defined as:
- •approx. 3-5 bowel movements per week,
- •of which 1-2 usually cause discomfort e.g., straining, lumpy or hard stools, sensation of incomplete evacuation or anorectal obstructions/blockage
- •Availability and presence in the trial unit for approx. 4 hours/ week for 4 weeks
- •Women of childbearing potential must be using a medically approved method of contraception OR women must be postmenopausal for at least 12 months prior to study entry
- •Signed informed consent form
排除标准
- •Fasting blood glucose <4.4 mmol/L (<80 mg/dL) or >10 mmol/L (>180 mg/dL) (capillary)
- •BMI <18.5 kg/m² or ≥35 kg/m²
- •Change in body weight ≥10 % within the last 3 months
- •Major medical or surgical event requiring hospitalization within the last 3 months
- •Acute gastrointestinal diseases including diarrhea and/or vomiting within the last 2 weeks
- •Presence of disease or intake of drug(s) / supplements other than antidiabetic treatment influencing digestion and absorption of carbohydrates or bowel habits (intake of laxatives in general allowed with exception see next criterion) (dietary / supplementary fibres allowed if stable dose since 1 month before study start)
- •Not willing to abstain from laxatives 2 days before the visits 1-4 and up to 24h after visits 1-4
- •Use of following medication/ supplementation within the last 4 weeks and during the study:
- •Intake of medications other than antidiabetic treatment known to affect glucose tolerance e.g., steroids, protease inhibitors or antipsychotics;
- •Intake of prebiotics or probiotics
- •Chronic intake of substances affecting blood coagulation (e.g. acetylic acid (100 mg as standard prophylactic treatment allowed when dose is stable 1 month prior to screening), anticoagulants, diuretics, thiazides (diuretics and thiazides allowed e.g. for hypertension treatment when dose is stable 1 month prior to screening)), which in the investigator's opinion would impact patient safety
- •Severe liver, renal or cardiac disease
- •Hereditary problems of galactose or fructose intolerance, lactase deficiency or glucose-galactose malabsorption
- •Suspicion of alcohol abuse (defined as an average daily intake of more than one litre of beer per day or equivalent amount of alcohol in other beverages) or drug abuse
- •Known or suspected allergy to the investigational drug(s) or other components of the study drug(s)
- •Acute inflammatory bowel disease (ulcerative colitis, Crohn's disease), gastrointestinal obstruction or subocclusive syndrome, perforations or risk of perforation in gastrointestinal tract, abdominal pain of undetermined cause
- •Known history of human immunodeficiency virus (HIV), hepatitis B and/or C
- •Pregnancy, lactation
- •Clinically relevant findings as established by medical history, physical examination, clinical laboratory and/or vital signs
- •Participation in another interventional study with an investigational drug or an investigational medical device within 30 days prior to start of study or during the study
研究组 & 干预措施
Laevolac crystals 20 g
Experimental
Lactulose crystals, oral intake, 20 g single dose
干预措施: Lactulose crystals 20 g (Drug)
Laevolac crystals 30 g
Experimental
Lactulose crystals, oral intake, 30 g single dose
干预措施: Lactulose crystals 30 g (Drug)
Laevolac liquid 20 g
Experimental
Lactulose liquid, oral intake, 20 g single dose
干预措施: Lactulose liquid 20 g (Drug)
Laevolac liquid 30 g
Experimental
Lactulose liquid, oral intake, 30 g single dose
干预措施: Lactulose liquid 30 g (Drug)
Glucose 30 g
Active Comparator
Glucose Monohydrate, oral intake, 33 g single dose
干预措施: Glucose (Drug)
Water
Placebo Comparator
Still water, oral intake, 250 mL single dose
干预措施: Still water (Drug)
结局指标
主要结局
Capillary blood glucose levels as baseline corrected AUC: AUCbaseline_c (0-180 minutes) [Baseline corrected area under curve from 0 to 180 minutes for blood glucose concentration (= Area under curve from 0 to 180 minutes minus baseline*180 minutes)]
时间窗: 0 - 180 minutes, during 4 study visits
次要结局
- Time to reach maximum blood glucose concentration (Tmax)(0 - 180 minutes, during 4 study visits)
- Maximum increase of blood glucose concentration (Max_increase)(0 - 180 minutes, during 4 study visits)
- Maximum blood glucose concentration (Cmax)(0 - 180 minutes, during 4 study visits)
- Relative maximum increase of blood glucose concentration (Max_increase_rel)(0 - 180 minutes, during 4 study visits)
- Total area under curve from 0 to 180 minutes for blood glucose concentration (AUC(0-180 minutes))(0 - 180 minutes, during 4 study visits)
- Incremental area under curve from 0 to 180 minutes for blood glucose concentration, i.e., above baseline levels for blood glucose concentration after oral intake of Laevolac crystals/liquid or control products (iAUC(0-180min))(0 - 180 minutes, during 4 study visits)
研究者
研究点 (1)
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