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

Effects of Artificial Sweeteners on Glucose Metabolism in Patients With Type 2 Diabetes -A Multi-Center Randomized Controlled Clinical Trial(SWEETS)

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

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Dietary supplement: sucralose

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jing Ma, professor; Phone Number: 3083 58752345; Email: cherry1996@live.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • RenJi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: placebo; intake 200 ml water daily for 3 months	Dietary supplement: sucralose; daily intake different dose of artificial sweeteners sucralose or placebo
EXPERIMENTAL: low dose sucrolose group; intake 12.3mg sucralose in 200 ml water daily for 3 months	Dietary supplement: sucralose; daily intake different dose of artificial sweeteners sucralose or placebo
EXPERIMENTAL: moderate dose sucrolose group; intake 73.8mg sucralose in 200ml water daily for 3 months	Dietary supplement: sucralose; daily intake different dose of artificial sweeteners sucralose or placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Collaborators: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; ShiBei Hospital , JingAn District, Shanghai; PuNan Hospital ,Shanghai
• Investigators: Principal Investigator: Jing Ma, professor, RenJi Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2019
• Primary Completion (ANTICIPATED): August 30, 2021
• Study Completion (ANTICIPATED): September 30, 2021

Study Registration Dates

• First Submitted: November 30, 2019
• First Submitted That Met QC Criteria: November 30, 2019
• First Posted (ACTUAL): December 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 4, 2019
• Last Update Submitted That Met QC Criteria: November 30, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: glucose metabolism; artificial sweetners; type 2 diabetic patients
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: T2DM20190619

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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