- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03352596
Low Fructose Diet in Diabetes Type 2
November 20, 2017 updated by: Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
Effects of Low Fructose Diet on Glycemic Control in Patients With Type 2 Diabetes
Diabetes is one of the most common and chronic diseases in the world, with the prevalence and incidence of this disease rising in most societies, especially in Iran.
Suitable treatments for type 2 diabetes include changing lifestyle with exercise, nutrition, and drug use.
New research suggests that added sugar, especially fructose, is the main trigger for diabetes and pre-diabetes even more potent than other carbohydrates.
Fructose has a low glycemic index (23μg =) and slowly increases blood glucose levels.
Therefore, it is thought that replacing fructose instead of glucose can have a positive effect on glycemic control of diabetic patients..
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age of 70-40 years
- body mass index(BMI) between 18.5 and 27
- Type 2 diabetes People who only control their diabetes by using glucose lowering tablets Type 2 diabetes (1 to 10 years)
Exclusion Criteria:
- Pregnancy and lactation
- Thyroid gland disorders
- Kidney disease and inflammation
- Follow the weight loss regimen 6 months before starting the study
- Usage of fatty and fatty foods, fiber powder Vitamin A Mineral Supplements, Omega 3
- Taking glucocorticoid drugs and non-steroidal anti-inflammatory drugs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intervention group
Eight weeks of low fructose diet with a maximum of 12 g of fructose
|
|
|
No Intervention: control group
Eight weeks of regular diabetic diet with a 15%pro 30%fat 55%CHO
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
fasting blood suger(FBS)
Time Frame: 8 weeks
|
8 weeks
|
|
Homeostatic model assessment and insulin resistance(HOMA-IR)
Time Frame: 8weeks
|
8weeks
|
|
insulin
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Blood pressure
Time Frame: 8 weeks
|
8 weeks
|
|
Triglyceride
Time Frame: 8 weeks
|
8 weeks
|
|
LDL-C
Time Frame: 8 weeks
|
8 weeks
|
|
HDL-C
Time Frame: 8 weeks
|
8 weeks
|
|
Total cholestrole
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
October 1, 2017
Study Completion (Anticipated)
November 30, 2017
Study Registration Dates
First Submitted
November 13, 2017
First Submitted That Met QC Criteria
November 20, 2017
First Posted (Actual)
November 24, 2017
Study Record Updates
Last Update Posted (Actual)
November 24, 2017
Last Update Submitted That Met QC Criteria
November 20, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 93567
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Maastricht University Medical CenterPfizerCompleted
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