Skip to main content
OpenTrials
Completed

NCT Number: NCT01070238

Metabolic Response of Slow Released Carbohydrates in Diabetes Mellitus

The study was conducted

1. to investigate the superiority of isomaltulose in reduction of postprandial hyperglycemia 2. to describe the kinetics of glucose absorption after a load of isomaltulose 3. to demonstrate the safety of a single load of isomaltulose compared to sucrose in type 2 diabetic patients.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University Hospital Giessen and Marburg

Giessen, Hesse, 35392, Germany

About this study

Epidemiological studies have shown that postprandial hyperglycemia is associated with atherosclerotic diseases. Therefore, therapeutic strategies to reduce postprandial hyperglycemia are desirable. An effective way to improve postprandial glucose level is the use of carbohydrates with low glycemic index. Isomaltulose is a reducing disaccharide occurring naturally in honey and sugar cane juice, including products derived thereof. It is an isomer of sucrose and composed of glucose and fructose linked alpha-1,6 instead of alpha-1,2.

Isomaltulose has been reported to be digested more slowly than sucrose. Due to this property, lower and slower increases in blood glucose responses are expected for isomaltulose than sucrose. Early studies have demonstrated attenuated glycemic and insulin responses after isomaltulose ingestion than after sucrose. This study was performed to describe the postprandial glucose metabolism more comprehensively after bolus administration of different doses of isomaltulose compared to sucrose in type 2 diabetic patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis: type 2 diabetes according to WHO/ADA criteria for more than 1 yr
  • Adults aged 18-75 years old
  • HbA1c < 8%, fasting blood glucose < 140 mg/dl
  • For at least 2 months prior to visit 1, subjects must have been on a stable antidiabetic therapy regimen
  • Subjects willing to perform home blood glucose monitoring and to otherwise comply with study protocol requirements

Exclusion criteria

  • Type 1 diabetes mellitus
  • Pregnant or lactating women or women planning to become pregnant
  • Women who become pregnant will be withdrawn from the study
  • Clinically significant heart, liver, lung, or kidney disease
  • Drug or alcohol abuse
  • Concomitant therapy with systemic glucocorticoids or acarbose
  • Subjects unable to adhere to instructions during the qualification phase

Treatment and study plan

isomaltulose

Dietary Supplement

Primary outcomes

  1. Lower postprandial glucose and insulin responses after isomaltulose ingestion than after sucrose

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Collaborators

  • Numico Research

Registry information

Official study title

Explorative, Pilot Study With Cross-over Design on the Metabolic Response of Orally Applied Slow Released Carbohydrates in Diabetes Type 2 Patients

Important dates

First posted
Feb 17, 2010
Registry last updated
Feb 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.