Diabetes Nutrition Algorithms - Sugars: Galactose- & NCT01776099

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number	NCT01776099
Other study ID #	DiNA-S DiNA-F
Secondary ID
Status	Active, not recruiting
Phase	N/A
First received
Last updated
Start date	November 2012
Est. completion date	December 2021

Study information
Verified date	June 2020
Source	German Institute of Human Nutrition
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Interventional

Clinical Trial Summary

In animal models and retrospective studies, certain food components such as sugars and fiber have been detected as potential agents to influence development and progress of type 2 diabetes.

The DiNA study prospectively investigates, if non-soluble non-fermentable fibers (vs. soluble ones) and galactose (vs. palatinose) are capable to improvement metabolic parameters in patients with long-term type 2 diabetes and intensive insulin treatment.

Recruitment information / eligibility
Status	Active, not recruiting
Enrollment	60
Est. completion date	December 2021
Est. primary completion date	October 2021
Accepts healthy volunteers	No
Gender	All
Age group	18 Years to 79 Years
Eligibility	Inclusion Criteria: - type 2 diabetes, insulin-dependent - high insulin resistance Exclusion Criteria: - accompanying disease, medication or metabolic disorder, which interact with glucose metabolism or eating behavior (e.g. renal insufficiency, major cardial insuffiency, untreated hypothyreosis, corticoid treatment, depression and other psychiatric disorders...)

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Dietary supplement (4 arms, 2 active, 2 placebo)

Locations
Country	Name	City	State
Germany	Charité-Klinikum Benjamin Franklin	Berlin

Sponsors *(3)*
Lead Sponsor	Collaborator
German Institute of Human Nutrition	Firma Rettenmeier & Söhne (Company), German Center for Diabetes Research

Country where clinical trial is conducted

Germany,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	metabolic improvement of type 2 diabetes	metabolic improvement of type 2 diabetes, as to be shown via hyperinsulinemic-euglycaemic clamp, mixed-meal test and daily demand of insulin units	4 weeks

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Diabetes Nutrition Algorithms - Sugars: Galactose- and Fiber-induced Metabolic Improvement in the Dietetic Treatment of Type 2 Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

Study information

Clinical Trial Summary

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (3)

Country where clinical trial is conducted

Outcome