Back to resultsDiabetes Nutrition Algorithms - Sugars: Galactose- and Fiber-induced Metabolic Improvement in the Dietetic Treatment of Type 2 Diabetes (DiNA-S DiNA-F)
Primary Purpose
Type 2 Diabetes
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Dietary supplement (4 arms, 2 active, 2 placebo)
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring type 2 diabetes, nutrition, fibers
Eligibility 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...)
Sites / Locations
- Charité-Klinikum Benjamin Franklin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Placebo Comparator
Placebo Comparator
Active Comparator
Arm Label
pure galactose
pure palatinose
soluble non-fermentable fibers
non-soluble non-fermentable fibers
Arm Description
5 grams of galactose, three times a day with the main meals, duration: 4 weeks
5 grams of palatinose, three times a day with the main meals, duration: 4 weeks
5 grams of soluble non-fermentable fibers, three times a day with the main meals, duration: 4 weeks
5 grams of non-soluble non-fermentable fibers, three times a day with each main meal, duration: 4 weeks
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01776099
First Posted
January 23, 2013
Last Updated
June 23, 2020
Sponsor
German Institute of Human Nutrition
Collaborators
Firma Rettenmeier & Söhne (Company), German Center for Diabetes Research
1. Study Identification
Unique Protocol Identification Number
NCT01776099
Brief Title
Diabetes Nutrition Algorithms - Sugars: Galactose- and Fiber-induced Metabolic Improvement in the Dietetic Treatment of Type 2 Diabetes
Acronym
DiNA-S DiNA-F
Official Title
Diabetes Nutrition Algorithms - Sugars: Galactose- and Fiber-induced Metabolic Improvement in the Dietetic Treatment of Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
German Institute of Human Nutrition
Collaborators
Firma Rettenmeier & Söhne (Company), German Center for Diabetes Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
type 2 diabetes, nutrition, fibers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pure galactose
Arm Type
Active Comparator
Arm Description
5 grams of galactose, three times a day with the main meals, duration: 4 weeks
Arm Title
pure palatinose
Arm Type
Placebo Comparator
Arm Description
5 grams of palatinose, three times a day with the main meals, duration: 4 weeks
Arm Title
soluble non-fermentable fibers
Arm Type
Placebo Comparator
Arm Description
5 grams of soluble non-fermentable fibers, three times a day with the main meals, duration: 4 weeks
Arm Title
non-soluble non-fermentable fibers
Arm Type
Active Comparator
Arm Description
5 grams of non-soluble non-fermentable fibers, three times a day with each main meal, duration: 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary supplement (4 arms, 2 active, 2 placebo)
Primary Outcome Measure Information:
Title
metabolic improvement of type 2 diabetes
Description
metabolic improvement of type 2 diabetes, as to be shown via hyperinsulinemic-euglycaemic clamp, mixed-meal test and daily demand of insulin units
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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...)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas F.H. Pfeiffer, Prof. Dr. med.
Organizational Affiliation
German Institute for Human Nutrition
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité-Klinikum Benjamin Franklin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Diabetes Nutrition Algorithms - Sugars: Galactose- and Fiber-induced Metabolic Improvement in the Dietetic Treatment of Type 2 Diabetes
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