Clinical trial NCT01070238: Metabolic Response of Slow Released Carbohydrates in Diabetes Mellitus
Official title: Explorative, Pilot Study With Cross-over Design on the Metabolic Response of Orally Applied Slow Released Carbohydrates in Diabetes Type 2 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Type 2 Diabetes
Keywords: Isomaltulose
Slow Released Carbohydrates
Postprandial Glucose Metabolism
Type 2 diabetes
Lead sponsor: University of Giessen
Sponsor class: OTHER
Collaborators: name: Numico Research
First posted: 2010-02-17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Lower postprandial glucose and insulin responses after isomaltulose ingestion than after sucrose
Secondary outcomes:
Other outcomes:
Locations:
city: Giessen
country: Germany
facility: University Hospital Giessen and Marburg
state: Hessen
Study officials:
References:
citation: Ang M, Linn T. Comparison of the effects of slowly and rapidly absorbed carbohydrates on postprandial glucose metabolism in type 2 diabetes mellitus patients: a randomized trial. Am J Clin Nutr. 2014 Oct;100(4):1059-68. doi: 10.3945/ajcn.113.076638. Epub 2014 Jul 16.