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Completed

NCT Number: NCT05713058

Metabolic Effects of Early Time-restricted Carbohydrate Consumption

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Body Weight Body Weight Changes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutrition, Healthy Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliero-Universitaria Pisana

Pisa, PI, 56127, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eTRC diet

Behavioral

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

Behavioral

12-week dietary prescription with moderate energy restriction (approximately 200 kcal/day) without any recommendations on the distribution of macronutrients within the day

Primary outcomes

  1. Glycemic control

    Time frame: 12 weeks

    Change in plasma levels of glycated hemoglobin

Secondary outcomes

  1. Glucose tolerance

    Time frame: 12 weeks

    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)

  2. Body weight loss

    Time frame: 12 weeks

    Change in body weight

Other outcomes

  1. Daily glucose variability

    Time frame: 14 days

    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

  2. Beta cell function

    Time frame: 12 weeks

    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)

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero, Universitaria Pisana

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 6, 2023
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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