Metabolic Response of Slow Released Carbohydrates in Diabetes Mellitus

NCT01070238 | Completed Phase 1

• 1 other identifier: RA.4240.UKGiessen.021219.B
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The study was conducted

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

Conditions

Type 2 Diabetes

Keywords

Isomaltulose; Slow Released Carbohydrates; Postprandial Glucose Metabolism; Type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• Lower postprandial glucose and insulin responses after isomaltulose ingestion than after sucrose

Interventions

Isomaltulose DIETARY_SUPPLEMENT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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• Women who become pregnant will be withdrawn from the study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

Sponsors & Collaborators

• University of Giessen: lead
• Numico Research: collaborator

Study Sites (1)

University Hospital Giessen and Marburg

Giessen, Hesse, 35392, Germany

Location

Related Publications (1)

• 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.

  PMID: 25030779 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

isomaltulose

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 16, 2010
• First Posted: February 17, 2010
• Last Updated: February 17, 2010

Record last verified: 2002-11

Locations

DE (1)