Metabolic Effects of Early Time-restricted Carbohydrate Consumption

Obesity Clinical Trial

Official title:

Effects of Early Time-restricted Carbohydrate Consumption on Weight Loss and Glucose Homeostasis in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05713058
• Other study ID #: eTRC DIET
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2023
• Source: Azienda Ospedaliero, Universitaria Pisana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this clinical trial, the investigators aim to examine the impact of a 12-week early time-restricted carbohydrate consumption diet on weight loss and glucose metabolism in patients with overweight/obesity and type 2 diabetes

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• age 18-75 years

• both males and females

• type 2 diabetes

Exclusion Criteria:

• type 1 diabetes

• insulin treatment

• pharmacological treatment for weight loss

• pregnancy

• other acute or chronic conditions influencing body weight and glucose metabolism

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity
• Weight Loss

Intervention

Behavioral:
• eTRC diet
12-week dietary prescription with moderate energy restriction (approximately 200 kcal/day) focusing on the distribution of macronutrients within the day so as to avoid carbohydrate consumption after lunch
• Control diet
12-week dietary prescription with moderate energy restriction (approximately 200 kcal/day) without any recommendations on the distribution of macronutrients within the day

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria Pisana	Pisa	PI

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero, Universitaria Pisana

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Daily glucose variability	Glucose variability will be measured as the coefficient of variation (CV) of glucose levels recorded by continuous glucose monitoring over a 14-day period using a FreeStyle Libre 2 sensor	14 days
Other	Beta cell function	Beta cell function will be measured as the beta cell glucose sensitivity obtained from mathematical modeling of plasma glucose and C-peptide levels in response to a 180-minute mixed meal tolerance test (MMTT)	12 weeks
Primary	Glycemic control	Change in plasma levels of glycated hemoglobin	12 weeks
Secondary	Glucose tolerance	Glucose tolerance will be measured as the area under the curve of plasma glucose levels in response to a 180-minute mixed meal tolerance test (MMTT)	12 weeks
Secondary	Body weight loss	Change in body weight	12 weeks