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

Not Applicable

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Dietary Supplement: sucralose

• Registration Number: NCT04185662
• Lead Sponsor: RenJi Hospital

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.

Study Timeline

• Status Verified: 2019-11
• Study First Submitted: 2019-11-30
• Study First Submitted QC: 2019-11-30
• Last Update Submitted: 2019-11-30
• Study Start: 2019-12-01
• Study First Posted: 2019-12-04
• Last Update Posted: 2019-12-04
• Primary Completion: 2021-08-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	sucralose	intake 200 ml water daily for 3 months
low dose sucrolose group	sucralose	intake 12.3mg sucralose in 200 ml water daily for 3 months
moderate dose sucrolose group	sucralose	intake 73.8mg sucralose in 200ml water daily for 3 months

Primary Outcome Measures

Name	Time	Method
Fasting glucose	3 month	Fasting glucose change from baseline
postprandial blood sugar	3 month	postprandial blood glucose change from baseline
HbA1c	3 month	HbA1c change from baseline

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, Shanghai, China