NCT05713058

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

4.3 years

First QC Date

January 26, 2023

Last Update Submit

August 17, 2023

Conditions

Diabetes Mellitus, Type 2ObesityNutrition, HealthyWeight Loss

Outcome Measures

Primary Outcomes (1)

  • Glycemic control

    Change in plasma levels of glycated hemoglobin

    12 weeks

Secondary Outcomes (2)

  • Glucose tolerance

    12 weeks

  • Body weight loss

    12 weeks

Other Outcomes (2)

  • Daily glucose variability

    14 days

  • Beta cell function

    12 weeks

Study Arms (2)

eTRC diet

EXPERIMENTAL
Behavioral: eTRC diet

Control diet

ACTIVE COMPARATOR
Behavioral: Control diet

Interventions

eTRC dietBEHAVIORAL

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

eTRC diet
Control dietBEHAVIORAL

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

Control diet

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18-75 years
  • both males and females
  • type 2 diabetes

You may not qualify if:

  • type 1 diabetes
  • insulin treatment
  • pharmacological treatment for weight loss
  • pregnancy
  • other acute or chronic conditions influencing body weight and glucose metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero-Universitaria Pisana

Pisa, PI, 56127, Italy

Location

Related Publications (1)

  • Trico D, Masoni MC, Baldi S, Cimbalo N, Sacchetta L, Scozzaro MT, Nesti G, Mengozzi A, Nesti L, Chiriaco M, Natali A. Early time-restricted carbohydrate consumption vs conventional dieting in type 2 diabetes: a randomised controlled trial. Diabetologia. 2024 Feb;67(2):263-274. doi: 10.1007/s00125-023-06045-9. Epub 2023 Nov 16.

    PMID: 37971503DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityWeight Loss

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Andrea Natali, MD

    University of Pisa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor of Nutrition

Study Record Dates

First Submitted

January 26, 2023

First Posted

February 6, 2023

Study Start

March 1, 2019

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

August 21, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

IPD will be shared with other researchers only upon reasonable request to the PI

Locations

IT(1)