We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified November 2016 by Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition
Sponsor:
ClinicalTrials.gov Identifier:
NCT01776099
First Posted: January 25, 2013
Last Update Posted: November 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Firma Rettenmeier & Söhne (Company)
German Center for Diabetes Research
Information provided by (Responsible Party):
Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Diabetes Nutrition Algorithms - Sugars: Galactose- and Fiber-induced Metabolic Improvement in the Dietetic Treatment of Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition:

Primary Outcome Measures:
  • metabolic improvement of type 2 diabetes [ Time Frame: 4 weeks ]
    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: December 2018
Estimated Primary Completion Date: October 2018 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01776099


Contacts
Contact: Stefan Kabisch, Dr. med. 030 450 514 ext 429 stefan.kabisch@charite.de
Contact: Andreas F.H. Pfeiffer, Prof. Dr. med. 033200 88 2771 afhp@dife.de

Locations
Germany
Charité-Klinikum Benjamin Franklin Recruiting
Berlin, Germany, 12203
Contact: Stefan Kabisch, Dr. med.    030 450 514 ext 429    stefan.kabisch@charite.de   
Contact       diabetes@charite.de   
Sub-Investigator: Stefan Kabisch, Dr. med.         
Sponsors and Collaborators
German Institute of Human Nutrition
Firma Rettenmeier & Söhne (Company)
German Center for Diabetes Research
Investigators
Principal Investigator: Andreas F.H. Pfeiffer, Prof. Dr. med. German Institute for Human Nutrition
  More Information

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-S DiNA-F
First Submitted: January 23, 2013
First Posted: January 25, 2013
Last Update Posted: November 22, 2016
Last Verified: November 2016

Keywords provided by Prof. Dr. med. Andreas F. H. Pfeiffer, 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