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Metabolic Effects of Early Time-restricted Carbohydrate Consumption

Primary Purpose

Diabetes Mellitus, Type 2, Obesity, Nutrition, Healthy

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
eTRC diet
Control diet
Sponsored by
Azienda Ospedaliero, Universitaria Pisana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Azienda Ospedaliero-Universitaria Pisana

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

eTRC diet

Control diet

Arm Description

Outcomes

Primary Outcome Measures

Glycemic control
Change in plasma levels of glycated hemoglobin

Secondary Outcome Measures

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)
Body weight loss
Change in body weight

Full Information

First Posted
January 26, 2023
Last Updated
August 17, 2023
Sponsor
Azienda Ospedaliero, Universitaria Pisana
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1. Study Identification

Unique Protocol Identification Number
NCT05713058
Brief Title
Metabolic Effects of Early Time-restricted Carbohydrate Consumption
Official Title
Effects of Early Time-restricted Carbohydrate Consumption on Weight Loss and Glucose Homeostasis in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero, Universitaria Pisana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Obesity, Nutrition, Healthy, Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
eTRC diet
Arm Type
Experimental
Arm Title
Control diet
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
eTRC diet
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Control diet
Intervention Description
12-week dietary prescription with moderate energy restriction (approximately 200 kcal/day) without any recommendations on the distribution of macronutrients within the day
Primary Outcome Measure Information:
Title
Glycemic control
Description
Change in plasma levels of glycated hemoglobin
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Glucose tolerance
Description
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)
Time Frame
12 weeks
Title
Body weight loss
Description
Change in body weight
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Daily glucose variability
Description
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
Time Frame
14 days
Title
Beta cell function
Description
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)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Natali, MD
Organizational Affiliation
University of Pisa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliero-Universitaria Pisana
City
Pisa
State/Province
PI
ZIP/Postal Code
56127
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will be shared with other researchers only upon reasonable request to the PI

Learn more about this trial

Metabolic Effects of Early Time-restricted Carbohydrate Consumption

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