NCT03352596

Brief Summary

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..

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 13, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 24, 2017

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2017

Completed
Last Updated

November 24, 2017

Status Verified

August 1, 2017

Enrollment Period

9 months

First QC Date

November 13, 2017

Last Update Submit

November 20, 2017

Conditions

Fructose Metabolism Disorder

Outcome Measures

Primary Outcomes (3)

  • fasting blood suger(FBS)

    8 weeks

  • Homeostatic model assessment and insulin resistance(HOMA-IR)

    8weeks

  • insulin

    8 weeks

Secondary Outcomes (5)

  • Triglyceride

    8 weeks

  • Total cholestrole

    8 weeks

  • LDL-C

    8 weeks

  • HDL-C

    8 weeks

  • Blood pressure

    8 weeks

Study Arms (2)

intervention group

EXPERIMENTAL

Eight weeks of low fructose diet with a maximum of 12 g of fructose

Other: low frutose diet

control group

NO INTERVENTION

Eight weeks of regular diabetic diet with a 15%pro 30%fat 55%CHO

Interventions

low frutose dietOTHER
intervention group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 13, 2017

First Posted

November 24, 2017

Study Start

January 1, 2017

Primary Completion

October 1, 2017

Study Completion

November 30, 2017

Last Updated

November 24, 2017

Record last verified: 2017-08