Acute Effect of Rebaudioside A on Glucose Excursion During an Oral Glucose Tolerance Test in Type 2 Diabetes Mellitus

NCT03510624 | Completed Phase 1 DMC

• 1 other identifier: s61580
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Investigate the acute effect of the steviol glycoside, rebaudioside A, on the glucose excursion during an oral glucose tolerance test in 30 patients with type 2 diabetes mellitus.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Area under the curve (AUC) blood glucose concentrations during an OGTT

  Area under the curve blood glucose concentrations during an OGTT

  0 to 2 hours after glucose challenge

Secondary Outcomes (8)

• AUC glucose/insulin/glucagon

  -30 to 0 min of OGTT

• AUC glucose/insulin/glucagon

  0 to 30 min of OGTT

• AUC glucose/insulin/glucagon

  0 to 4 hours of OGTT

• Maximal blood glucose

  -30 min to 4 hours of OGTT

• Maximal blood glucose excursion

  -30 min to 4 hours of OGTT

Study Arms (2)

First rebaudioside A and then placebo

EXPERIMENTAL

Drug: Rebaudioside A; Drug: Placebo

First placebo and then rebaudioside A

EXPERIMENTAL

Drug: Rebaudioside A; Drug: Placebo

Interventions

Rebaudioside A DRUG

Rebaudioside A 3g

First placebo and then rebaudioside A; First rebaudioside A and then placebo

Placebo DRUG

Empty capsules

First placebo and then rebaudioside A; First rebaudioside A and then placebo

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated written informed consent
• Understand procedures
• Type 2 diabetes mellitus
• Body Mass Index (BMI): 25 - 40 kg/m2
• HbA1c: 6.5-8%
• Judged to be in good health

You may not qualify if:

• Subject is unable to
• Refrain from stevia leaves, stevia extracts or steviol glycoside-containing products from 5 days prior to administration of rebaudioside A or placebo until discharge from the unit after the OGTT on the consecutive day.
• Refrain from quinine-containing products from 72h prior to administration of rebaudioside A or placebo until discharge from the unit after the OGTT on the consecutive day.
• Maintain their habitual diets and physical activity patterns and refrain from engaging in strenuous physical activities from 72h prior to administration of rebaudioside A or placebo until discharge from the unit after the OGTT on the consecutive day.
• Refrain from grapefruit products from 14 days before study visit 1 until discharge from the unit after the OGTT on study visit 4.
• Refrain from alcohol from 24h prior to administration of rebaudioside A or placebo until discharge from the unit after the OGTT on the consecutive day.
• Refrain from caffeine containing products from 12h prior to administration of rebaudioside A or placebo until discharge from the unit after the OGTT on the consecutive day.
• Fast at least 5 hours prior to the administration of rebaudioside A or placebo on study days 1 and 3.
• Fast at least 10 hours prior to the study days 2 and 4.
• Women of childbearing potential (last menstruation less than 1 year prior to screening) who are pregnant, lactating or planning to become pregnant during the study.
• Individuals with other forms of diabetes
• Current or previous treatment with any diabetes drug within 3 months prior to screening, except for metformin.
• Symptomatic hyperglycemia requiring immediate therapy during screening, in the judgement of the principal investigator.
• Evidence of significant diabetic complications.
• History of pancreas or beta-cell transplantation.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Centrum Clinical Pharmacology

Leuven, Flanders, 3000, Belgium

Location

Related Publications (1)

• Simoens C, Philippaert K, Wuyts C, Goscinny S, Van Hoeck E, Van Loco J, Billen J, de Hoon J, Ampe E, Vangoitsenhoven R, Mertens A, Vennekens R, Van der Schueren B. Pharmacokinetics of Oral Rebaudioside A in Patients with Type 2 Diabetes Mellitus and Its Effects on Glucose Homeostasis: A Placebo-Controlled Crossover Trial. Eur J Drug Metab Pharmacokinet. 2022 Nov;47(6):827-839. doi: 10.1007/s13318-022-00792-7. Epub 2022 Sep 3.

  PMID: 36057030 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

rebaudioside A

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Bart Van der Schueren

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: April 27, 2018
• Study Start: November 9, 2018
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

BE (1)