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Diabetes Nutrition Algorithms - Galactose- and Fiber-induced Metabolic Improvement in the Dietetic Treatment of Type 2 Diabetes (DiNA)

This study is currently recruiting participants.
Verified January 2013 by German Institute of Human Nutrition
Sponsor:
Collaborators:
Deutsche Diabetes Gesellschaft (German Diabetes Society)
Firma Rettenmeier & Söhne (Company)
Information provided by (Responsible Party):
Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition
ClinicalTrials.gov Identifier:
NCT01776099
First received: January 23, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Type 2 Diabetes
 Dietary Supplement: Dietary supplement (4 arms, 2 active, 2 placebo)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Diabetes Nutrition Algorithms - Galactose- and Fiber-induced Metabolic Improvement in the Dietetic Treatment of Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by German Institute of Human Nutrition:

Primary Outcome Measures:
  • metabolic improvement of type 2 diabetes [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    metabolic improvement of type 2 diabetes, as to be shown via hyperinsulinemic-euglycaemic clamp, mixed-meal test and daily demand of insulin units


Estimated Enrollment: 60
Study Start Date: November 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: pure galactose
5 grams of galactose, three times a day with the main meals, duration: 4 weeks
 Dietary Supplement: Dietary supplement (4 arms, 2 active, 2 placebo)
Placebo Comparator: pure palatinose
5 grams of palatinose, three times a day with the main meals, duration: 4 weeks
 Dietary Supplement: Dietary supplement (4 arms, 2 active, 2 placebo)
Placebo Comparator: soluble non-fermentable fibers
5 grams of soluble non-fermentable fibers, three times a day with the main meals, duration: 4 weeks
 Dietary Supplement: Dietary supplement (4 arms, 2 active, 2 placebo)
Active Comparator: non-soluble non-fermentable fibers
5 grams of non-soluble non-fermentable fibers, three times a day with each main meal, duration: 4 weeks
 Dietary Supplement: Dietary supplement (4 arms, 2 active, 2 placebo)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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...)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776099

Contacts
Contact: Stefan Kabisch 030 8445 3474 stefan.kabisch@charite.de
Contact: Gabriele Klampke diabetes@charite.de

Locations
Germany
Charité-Klinikum Benjamin Franklin Recruiting
Berlin, Germany, 12203
Contact: Stefan Kabisch     030 8445 3474     stefan.kabisch@charite.de    
Contact         diabetes@charite.de    
Sub-Investigator: Stefan Kabisch            
Sponsors and Collaborators
German Institute of Human Nutrition
Deutsche Diabetes Gesellschaft (German Diabetes Society)
Firma Rettenmeier & Söhne (Company)
Investigators
Principal Investigator: Andreas F.H. Pfeiffer, Prof. Dr. German Institute for Human Nutrition
  More Information

No publications provided

Responsible Party: Prof. Dr. med. Andreas F. H. Pfeiffer, Director of the Department for Clinical Nutrition, German Institute of Human Nutrition
ClinicalTrials.gov Identifier: NCT01776099     History of Changes
Other Study ID Numbers: DiNA-1
Study First Received: January 23, 2013
Last Updated: January 23, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by German Institute of Human Nutrition:
type 2 diabetes
nutrition
fibers

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013