NCT04185662

Brief Summary

To investigate the effects of artificial sweeteners on glucose metabolism in newly diagnosed type 2 diabetic patients

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 30, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

December 4, 2019

Status Verified

November 1, 2019

Enrollment Period

1.7 years

First QC Date

November 30, 2019

Last Update Submit

November 30, 2019

Conditions

Diabetes Mellitus, Type 2

Keywords

artificial sweetnersglucose metabolismtype 2 diabetic patients

Outcome Measures

Primary Outcomes (3)

  • Fasting glucose

    Fasting glucose change from baseline

    3 month

  • postprandial blood sugar

    postprandial blood glucose change from baseline

    3 month

  • HbA1c

    HbA1c change from baseline

    3 month

Study Arms (3)

placebo

PLACEBO COMPARATOR

intake 200 ml water daily for 3 months

Dietary Supplement: sucralose

low dose sucrolose group

EXPERIMENTAL

intake 12.3mg sucralose in 200 ml water daily for 3 months

Dietary Supplement: sucralose

moderate dose sucrolose group

EXPERIMENTAL

intake 73.8mg sucralose in 200ml water daily for 3 months

Dietary Supplement: sucralose

Interventions

sucraloseDIETARY_SUPPLEMENT

daily intake different dose of artificial sweeteners sucralose or placebo

low dose sucrolose groupmoderate dose sucrolose groupplacebo

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants with newly diagnosed type 2 diabetes, diagnosed by World Health Organization criteria, were recruited from outpatient of the Endocrinology Department in Shanghai Renji Hospital, Shanghai PuNan hospital，Shanghai ShiBei hospital, shanghai xinhua hospital, chongming branch;
  • FBG≤ 9 mmol/L, HbA1c≤ 7% ;without any oral hypoglycemic agents or insulin,
  • Age ≥30 and ≤ 60 years old.
  • BMI \>24 and \<28 kg/m2; --no regular consumption of artificial sweeteners or foods that have added much sweeteners.(eg:Coca-Cola zero), no sucralose intolerance.

You may not qualify if:

  • patients who had a history of acute and chronic diarrhea or constipation or severe chronic gastrointestinal disease..
  • underwent enterectomy or other abdominal surgery (e.g., gallbladder removal) within one year;
  • take antibiotics, antidiarrheic, antispasmodic, steroids and immune agents within three months.
  • Patients who had a history of abnormal renal function(creatinine \>132μmol/L), active liver disease(ALT were 2.5 times higher than the normal upper limit), or accompany with other sever diseases, such as severe infection, severe anemia, neutropenia and mental illness.
  • Other serious heart disease, such as congenital heart disease, rheumatic heart disease, hypertrophic or dilated heart disease,cardiac function(NYHA) classification\>level III.
  • A history of acute complications such as diabetic ketoacidosis or hypertonic coma within 3 months.
  • pregancy
  • Allergic to sweeteners.
  • participant in any clinical trail within 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

trichlorosucrose

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jing Ma, professor

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Ma, professor

CONTACT

58752345cherry1996@live.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2019

First Posted

December 4, 2019

Study Start

December 1, 2019

Primary Completion

August 30, 2021

Study Completion

September 30, 2021

Last Updated

December 4, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)