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Blood Glucose Response After Oral Intake of Lactulose in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02968498
Recruitment Status : Completed
First Posted : November 18, 2016
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Fresenius Kabi

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.


Condition or disease Intervention/treatment Phase
Blood Glucose Dietary Supplement: Lactulose crystals 10 g Dietary Supplement: Lactulose crystals 20 g Dietary Supplement: Lactulose liquid 10 g Dietary Supplement: Lactulose liquid 20 g Dietary Supplement: Oral glucose 20 g Dietary Supplement: Still water Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Blood Glucose Response After Oral Intake of Lactulose in Healthy Volunteers
Study Start Date : November 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Active Comparator: Study arm 1
Lactulose crystals 10 g vs lactulose crystals 20 g vs oral glucose 20 g vs still water
Dietary Supplement: Lactulose crystals 10 g
White or almost white crystalline powder used as food ingredient. The products will be provided in sachets to be dissolved in 250 mL water.

Dietary Supplement: Lactulose crystals 20 g
White or almost white crystalline powder used as food ingredient. The products will be provided in sachets to be dissolved in 250 mL water.

Dietary Supplement: Oral glucose 20 g
White crystalline powder used as food ingredient. To standardise for 20 g glucose, 22 g glucose monohydrate will be used. The products will be provided in sachets to be dissolved in 250 mL water.
Other Name: glucose monohydrate

Dietary Supplement: Still water
Still water will be used. Water from the same source will be also used to dissolve investigational and control products.

Active Comparator: Study arm 2
Lactulose liquid 10 g vs lactulose liquid 20 g vs oral glucose 20 g vs still water
Dietary Supplement: Lactulose liquid 10 g
Clear, viscous liquid, colourless or pale brownish-yellow liquid syrup (solution). The products will be provided in sachets to be dissolved in 250 mL water.

Dietary Supplement: Lactulose liquid 20 g
Clear, viscous liquid, colourless or pale brownish-yellow liquid syrup (solution). The products will be provided in sachets to be dissolved in 250 mL water.

Dietary Supplement: Oral glucose 20 g
White crystalline powder used as food ingredient. To standardise for 20 g glucose, 22 g glucose monohydrate will be used. The products will be provided in sachets to be dissolved in 250 mL water.
Other Name: glucose monohydrate

Dietary Supplement: Still water
Still water will be used. Water from the same source will be also used to dissolve investigational and control products.




Primary Outcome Measures :
  1. Capillary blood glucose levels as incremental area under the curve (iAUC) above baseline (iAUC(0-180min)) [ Time Frame: 0-180 min ]

Secondary Outcome Measures :
  1. Maximum blood glucose concentration (Cmax) [ Time Frame: 0-180 min ]
  2. Maximum increase of blood glucose concentration (Max_increase) [ Time Frame: 0-180 min ]
    Cmax minus baseline value

  3. Relative maximum increase of blood glucose concentration(Max_increase rel) [ Time Frame: 0-180 min ]
    Cmax / baseline value

  4. Time to reach maximum blood glucose concentration (Tmax) [ Time Frame: 0-180 min ]
  5. First time to reach baseline again after increase or decrease in blood glucose (Tbaseline) [ Time Frame: 0-180 min ]
  6. Total area under curve from 0 to 180 min for blood glucose concentration (AUC(0-180min)) [ Time Frame: 0-180 min ]
  7. Baseline corrected area under curve from 0 to 180 min for blood glucose concentration (AUCbase_c(0-180min)) [ Time Frame: 0-180 min ]
    Area under curve from 0 to 180 min minus baseline*180min

  8. Adverse events (AEs) [ Time Frame: After screening till study day 22 (+24 hours) ]
  9. Gastrointestinal tolerability (assessed by subject's questionnaire) [ Time Frame: 180 min ]
  10. Gastrointestinal tolerability (assessed by subject's questionnaire) [ Time Frame: 24 hours post-dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02968498


Locations
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Germany
CRO BioTeSys GmbH
Esslingen, Germany, 73728
Sponsors and Collaborators
Fresenius Kabi
Investigators
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Principal Investigator: Daniel Menzel, MD CRO BioTeSys GmbH

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Responsible Party: Fresenius Kabi
ClinicalTrials.gov Identifier: NCT02968498     History of Changes
Other Study ID Numbers: Lact-001-CEN
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Fresenius Kabi:
Blood glucose level
Oral intake
Lactulose
Healthy volunteers
Additional relevant MeSH terms:
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Methamphetamine
Lactulose
Gastrointestinal Agents
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors