Metabolic Response of Slow Released Carbohydrates in Diabetes Mellitus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Isomaltulose

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No