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Blood Glucose Response After Oral Intake of Lactulose in Mildly Constipated Patients With Diabetes Mellitus Type 2

NCT03666546 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-04-12

No results posted yet for this study

Summary

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Lactulose crystals 20 g

White or almost white crystalline powder. The product will be provided in sachets to be dissolved in 250 mL water.

DRUG

Lactulose crystals 30 g

White or almost white crystalline powder. The products will be provided in sachets to be dissolved in 250 mL water.

DRUG

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.

DRUG

Lactulose liquid 30 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.

DRUG

Glucose

White crystalline powder. To standardise for 30 g glucose, 33 g glucose monohydrate will be used. The products will be provided in sachets to be dissolved in 250 mL water.

DRUG

Still water

250 mL still water will be used. Water from the same source will be also used to dissolve investigational and control products

Sponsors & Collaborators

  • Fresenius Kabi

    lead INDUSTRY

Principal Investigators

  • Thomas Pieber, Prof. MD · Head and Chair of Department of Internal Medicine, Division of Endocrinology and Diabetology, Medical University, Graz, Austria

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-26
Primary Completion
2019-03-05
Completion
2019-03-08

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03666546 on ClinicalTrials.gov