Diabetes Mellitus, Type 2NCT05713058
Metabolic Effects of Early Time-restricted Carbohydrate Consumption
A study testing eTRC diet in people with Diabetes Mellitus, Type 2 and Obesity, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity, Nutrition, Healthy
- What is being tested?
- eTRC diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2019to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-75 years
- both males and females
- type 2 diabetes
Who cannot join
- type 1 diabetes
- insulin treatment
- pharmacological treatment for weight loss
- pregnancy
- other acute or chronic conditions influencing body weight and glucose metabolism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Early Time-restricted Carbohydrate Consumption on Weight Loss and Glucose Homeostasis in Patients With Type 2 Diabetes
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
- Conditions
- Diabetes Mellitus, Type 2, Obesity, Nutrition, Healthy, Weight Loss
- Being tested
- eTRC diet, Control diet
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eTRC dietBehavioural
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 dietBehavioural
12-week dietary prescription with moderate energy restriction (approximately 200 kcal/day) without any recommendations on the distribution of macronutrients within the day
| Study group | Role | What they receive |
|---|---|---|
| eTRC diet | Experimental | Not described Receives: Behavioral: eTRC diet |
| Control diet | Active comparator | Not described Receives: Behavioral: Control diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
Change in plasma levels of glycated hemoglobin
Measured: 12 weeks
Secondary outcomes (2)
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)
Measured: 12 weeks
Body weight loss
Change in body weight
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start1 Mar 2019
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Natali, Azienda Ospedaliero, Universitaria Pisana
- Investigators
- Andrea Natali, MD, Principal investigator, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713058
- Sponsor's protocol ID
- eTRC DIET
- Status last verified
- Aug 2023
- First submitted
- 26 Jan 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared with other researchers only upon reasonable request to the PI
Publications
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.
PubMed 37971503
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Time-restricted Carbohydrate Consumption on Weight Loss and Glucose Homeostasis in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05713058
- Acronym / sponsor ID
- eTRC DIET
- Conditions
- Diabetes Mellitus, Type 2, Obesity, Nutrition, Healthy, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eTRC diet | Experimental | Behavioral: eTRC diet |
| Control diet | Active comparator | Behavioral: Control diet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18-75 years
- both males and females
- type 2 diabetes
Key exclusion criteria (5 listed)
- type 1 diabetes
- insulin treatment
- pharmacological treatment for weight loss
- pregnancy
- other acute or chronic conditions influencing body weight and glucose metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eTRC diet12-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 | Behavioural | eTRC diet |
| Control diet12-week dietary prescription with moderate energy restriction (approximately 200 kcal/day) without any recommendations on the distribution of macronutrients within the day | Behavioural | Control diet |
Primary outcome
Glycemic control
Time frame: 12 weeks
Change in plasma levels of glycated hemoglobin
2 secondary outcomes
Glucose tolerance
Time frame: 12 weeks
Body weight loss
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Derived from this study: PubMed 37971503Trico 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.
- Individual participant dataSharing planned: No. IPD will be shared with other researchers only upon reasonable request to the PI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Natali, MD principal investigator
University of Pisa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eTRC diet in people with Diabetes Mellitus, Type 2 and Obesity, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05713058, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.