Clinical trial NCT02968498: Blood Glucose Response After Oral Intake of Lactulose in Healthy Volunteers
Official title: Blood Glucose Response After Oral Intake of Lactulose in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Glucose
Keywords: Blood glucose level
Oral intake
Lactulose
Healthy volunteers
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
First posted: 2016-11-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Smoker
* 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

Primary outcomes:
measure: Capillary blood glucose levels as incremental area under the curve (iAUC) above baseline (iAUC(0-180min))
timeFrame: 0-180 min
Secondary outcomes:
measure: Maximum blood glucose concentration (Cmax)
timeFrame: 0-180 min
measure: Maximum increase of blood glucose concentration (Max_increase)
timeFrame: 0-180 min
measure: Relative maximum increase of blood glucose concentration(Max_increase rel)
timeFrame: 0-180 min
measure: Time to reach maximum blood glucose concentration (Tmax)
timeFrame: 0-180 min
measure: First time to reach baseline again after increase or decrease in blood glucose (Tbaseline)
timeFrame: 0-180 min
measure: Total area under curve from 0 to 180 min for blood glucose concentration (AUC(0-180min))
timeFrame: 0-180 min
measure: Baseline corrected area under curve from 0 to 180 min for blood glucose concentration (AUCbase_c(0-180min))
timeFrame: 0-180 min
measure: Adverse events (AEs)
timeFrame: After screening till study day 22 (+24 hours)
measure: Gastrointestinal tolerability (assessed by subject's questionnaire)
timeFrame: 180 min
measure: Gastrointestinal tolerability (assessed by subject's questionnaire)
timeFrame: 24 hours post-dose
Other outcomes:
Locations:
city: Esslingen
country: Germany
facility: CRO BioTeSys GmbH
Study officials:
affiliation: CRO BioTeSys GmbH
name: Daniel Menzel, MD
role: PRINCIPAL_INVESTIGATOR
References: