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

NCT ID: NCT01776099

Last Updated: 2020-06-24

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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pure galactose

5 grams of galactose, three times a day with the main meals, duration: 4 weeks

Group Type ACTIVE_COMPARATOR

Dietary supplement (4 arms, 2 active, 2 placebo)

Intervention Type DIETARY_SUPPLEMENT

pure palatinose

5 grams of palatinose, three times a day with the main meals, duration: 4 weeks

Group Type PLACEBO_COMPARATOR

Dietary supplement (4 arms, 2 active, 2 placebo)

Intervention Type DIETARY_SUPPLEMENT

soluble non-fermentable fibers

5 grams of soluble non-fermentable fibers, three times a day with the main meals, duration: 4 weeks

Group Type PLACEBO_COMPARATOR

Dietary supplement (4 arms, 2 active, 2 placebo)

Intervention Type DIETARY_SUPPLEMENT

non-soluble non-fermentable fibers

5 grams of non-soluble non-fermentable fibers, three times a day with each main meal, duration: 4 weeks

Group Type ACTIVE_COMPARATOR

Dietary supplement (4 arms, 2 active, 2 placebo)

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Dietary supplement (4 arms, 2 active, 2 placebo)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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...)
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Firma Rettenmeier & Söhne (Company)

UNKNOWN

Sponsor Role collaborator

German Center for Diabetes Research

OTHER

Sponsor Role collaborator

German Institute of Human Nutrition

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. med. Andreas F. H. Pfeiffer

Director of the Department for Clinical Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas F.H. Pfeiffer, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

German Institute for Human Nutrition

Locations

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Charité-Klinikum Benjamin Franklin

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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DiNA-S DiNA-F

Identifier Type: -

Identifier Source: org_study_id

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