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Effects of Artificial Sweeteners on Glucose Metabolism in Patients With Type 2 Diabetes (SWEETS)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
sucralose
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring artificial sweetners, glucose metabolism, type 2 diabetic patients

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Renji Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

placebo

low dose sucrolose group

moderate dose sucrolose group

Arm Description

intake 200 ml water daily for 3 months

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

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

Outcomes

Primary Outcome Measures

Fasting glucose
Fasting glucose change from baseline
postprandial blood sugar
postprandial blood glucose change from baseline
HbA1c
HbA1c change from baseline

Secondary Outcome Measures

Full Information

First Posted
November 30, 2019
Last Updated
November 30, 2019
Sponsor
RenJi Hospital
Collaborators
ShiBei Hospital , JingAn District, Shanghai, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, PuNan Hospital ,Shanghai
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1. Study Identification

Unique Protocol Identification Number
NCT04185662
Brief Title
Effects of Artificial Sweeteners on Glucose Metabolism in Patients With Type 2 Diabetes
Acronym
SWEETS
Official Title
Effects of Artificial Sweeteners on Glucose Metabolism in Patients With Type 2 Diabetes -A Multi-Center Randomized Controlled Clinical Trial(SWEETS)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2019 (Anticipated)
Primary Completion Date
August 30, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
Collaborators
ShiBei Hospital , JingAn District, Shanghai, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, PuNan Hospital ,Shanghai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To investigate the effects of artificial sweeteners on glucose metabolism in newly diagnosed type 2 diabetic patients
Detailed Description
Artificial sweeteners are among the most widely used food additives worldwide. Artificial sweeteners consumption is considered safe and beneficial owing to their low caloric content. However, recent studies demonstrated that consumption of commonly used artificial sweeteners formulations drives the development of glucose intolerance in healthy human subjects. However,the effects of artificial sweeter on glucose metabolism in newly diagnosed type 2 diabetic patients remains unknown. Thus, different doses of sweeteners will be given to newly diagnosed type 2 diabetic patients to investigate the effects of artificial sweeteners on glucose metabolism.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
artificial sweetners, glucose metabolism, type 2 diabetic patients

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
intake 200 ml water daily for 3 months
Arm Title
low dose sucrolose group
Arm Type
Experimental
Arm Description
intake 12.3mg sucralose in 200 ml water daily for 3 months
Arm Title
moderate dose sucrolose group
Arm Type
Experimental
Arm Description
intake 73.8mg sucralose in 200ml water daily for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
sucralose
Intervention Description
daily intake different dose of artificial sweeteners sucralose or placebo
Primary Outcome Measure Information:
Title
Fasting glucose
Description
Fasting glucose change from baseline
Time Frame
3 month
Title
postprandial blood sugar
Description
postprandial blood glucose change from baseline
Time Frame
3 month
Title
HbA1c
Description
HbA1c change from baseline
Time Frame
3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Ma, professor
Phone
58752345
Ext
3083
Email
cherry1996@live.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Ma, professor
Organizational Affiliation
RenJi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Artificial Sweeteners on Glucose Metabolism in Patients With Type 2 Diabetes

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