PreDiabetesNCT05161897
Individualized Nutrition Therapy for Preventing or Delaying Onset of Type-2 Diabetes
A study testing Individualized Nutrition Therapy in people with PreDiabetes and Cardiovascular Diseases, run by George Mason University at 1 site in United States.
Trial summary
The overall aim of this feasibility study is to conduct a randomized, controlled intervention providing adults with prediabetes either an individualized nutrition therapy (INT) intervention that contains individualized dietary goal-setting components, the goal being to improve blood glucose, reduce CVD risk factors… Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- PreDiabetes, Cardiovascular Diseases
- What is being tested?
- Individualized Nutrition Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2022to 14 Dec 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 45-65 years
- Any race or ethnicity
- Those who have or may have pre-diabetes (will be screened to confirm)
- HbA1c level between 5.7%-6.4% (will be screened to confirm)
- BMI between 25 and 39.9 kg/m2
- Taking stable doses of antihypertensive and/or cholesterol-lowering medications for 3 months or more prior to being enrolled in the study
Who cannot join
- Pregnant or lactating
- Individuals outside of the HbA1c and BMI inclusion ranges
- Those with active cancer, thyroid, kidney, liver, and pancreatic diseases
- Heavy cigarette smokers (25 cigarettes per day or more)
- Heavy drinkers (>12 alcoholic drinks per week on average)
- Taking more than one hypoglycemic agent (blood sugar lowering medications)
Show all 12Show fewer
- Having major dietary restrictions
- Participating in any weight loss or dietary program/taking prescribed appetite suppressants
- Participating in another investigational study at the same time as this study
- Anyone who refuses to follow dietary recommendations
- Anyone who refuses to wear the continuous glucose monitoring device as instructed
- Anyone who will not fill out their food dairy and automated self-administered dietary assessment tool
Trial locations and contacts
1 site in 1 country.
United States1 site
Population Health Center Clinic George Mason University
Fairfax, Virginia, 22030
About this study
The overall aim of this feasibility study is to conduct a randomized, controlled intervention providing adults with prediabetes either an individualized nutrition therapy (INT) intervention that contains individualized dietary goal-setting components, the goal being to improve blood glucose, reduce CVD risk factors, and therefore postpone the onset of diabetes and related cardiovascular disease, or standard-of-care generalized dietary recommendation (SOC). The hypothesis is that the INT arm will experience greater benefits in some or all of the following primary outcome variables: improvement in postprandial blood glucose, oral glucose tolerance test, fasting insulin, and calculated insulin sensitivity (HOMA) in individuals with prediabetes. Secondary outcome variables are improved markers of inflammation, antioxidant status, blood lipids, blood pressure, and endothelial function.
- Conditions
- PreDiabetes, Cardiovascular Diseases
- Being tested
- Individualized Nutrition Therapy
- Medical subject headings
- Prediabetic State, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Nutrition TherapyOther
Explained in arm/group description.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | This arm will receive generalized nutrition therapy throughout the study. Participants will receive dietary recommendations based on their needs and will be educated about the recommended amount of carbohydrates for each meal and the carbohydrate choices. Participants will also be provided with a CGM device; however, participants will be blind to the CGM recordings until the end of the study. |
| Intervention Group | Experimental | This arm will receive both individualized nutrition therapy and generalized nutrition therapy throughout the study.
Participants will receive dietary recommendations based on their needs and will be educated about the recommended amount of carbohydrates for each meal and the carb choices. Participants will also be provided with a CGM device and will be educated to review their blood glucose measurements and record above range measures along with time, types and amount of food items consumed, cooking method, and any type of physical activity within one hour before or after the meal. This information will be reviewed by one of the research staff at each visit and will be used to set individualized goals for modifying diet and controlling blood glucose. Participants will visit every 10 days for 30 days to conduct measurements, replace their CGM, set new goals based on their food diary and CGM recordings, and receive further dietary recommendations. Receives: Other: Individualized Nutrition Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in interstitial glucose concentrations [Time Frame: baseline, 10 days, 20 days, and 30 days]
Evaluating change in 24hr interstitial glucose concentrations and glycemic variability from baseline measure using a Continuous Glucose Monitoring (CGM) device
Measured: baseline, 10 days, 20 days, and 30 days
Change in insulin sensitivity [Time Frame: baseline, 10 days, 20 days, and 30 days]
Change in insulin sensitivity from baseline measure will be assessed using the homeostatic model of insulin resistance (HOMA-IR) and insulin secretion (HOMA-β)
Measured: baseline, 10 days, 20 days, and 30 days
Change in glucose tolerance [Time Frame: baseline, 10 days, 20 days, and 30 days]
Change in glucose tolerance from baseline measures will be assessed using an oral glucose tolerance test
Measured: baseline, 10 days, 20 days, and 30 days
Secondary outcomes (7)
Change in inflammation status [Time Frame: baseline, 10 days, 20 days, and 30 days]
As assessed by change in blood concentration of c-reactive protein (CRP)
Measured: baseline, 10 days, 20 days, and 30 days
Change in lipid profiles [Time Frame: baseline, 10 days, 20 days, and 30 days]
As assessed by change in blood concentration of total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and oxidized LDL (ox-LDL)
Measured: baseline, 10 days, 20 days, and 30 days
Change in markers of endothelial function [Time Frame: baseline, 10 days, 20 days, and 30 days]
As assessed by blood concentrations of nitric oxide (NO) and endothelin-1 (ET-1)
Measured: baseline, 10 days, 20 days, and 30 days
Change in blood pressure [Time Frame: baseline, 10 days, 20 days, and 30 days]
Change in blood pressure from baseline measures as assessed by measuring resting blood pressure
Measured: baseline, 10 days, 20 days, and 30 days
Change in atherogenic risk ratios [Time Frame: baseline, 10 days, 20 days, and 30 days]
Change in atherogenic risk ratios from baseline measures as assessed by (AIP) = Log (TG/HDL-C), CRI-I(TC/HDL-C), CRI-II(LDL-C/HDL-C), AC(TC-HDL-C/HDL-C)
Measured: baseline, 10 days, 20 days, and 30 days
Change in antioxidant status [Time Frame: baseline, 10 days, 20 days, and 30 days]
Change in antioxidant status from baseline measure as assessed by measuring total antioxidant capacity (TAC) in blood
Measured: baseline, 10 days, 20 days, and 30 days
Change in dietary intake [Time Frame: baseline, 10 days, 20 days, and 30 days]
Change in dietary intake from baseline measures using data from ASA24 survey for one day in each time frame
Measured: baseline, 10 days, 20 days, and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start25 Aug 2022
- Primary completion14 Dec 2023
- Study completion14 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Mason University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raedeh Basiri, George Mason University
- Investigators
- Raedeh Basiri, PhD, Principal investigator, George Mason University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161897
- Sponsor's protocol ID
- 1825534-1
- Status last verified
- May 2024
- First submitted
- 2 Nov 2021
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Nutrition Therapy for Preventing or Delaying Onset of Type-2 Diabetes
- ClinicalTrials.gov ID
- NCT05161897
- Acronym / sponsor ID
- 1825534-1
- Conditions
- PreDiabetes, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- George Mason UniversityUniversity, hospital or other
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 17 Dec 2021 (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.
The overall aim of this feasibility study is to conduct a randomized, controlled intervention providing adults with prediabetes either an individualized nutrition therapy (INT) intervention that contains individualized dietary goal-setting components, the goal being to improve blood glucose, reduce CVD risk factors, and therefore postpone the onset of diabetes and related cardiovascular disease, or standard-of-care generalized dietary recommendation (SOC). The hypothesis is that the INT arm will experience greater benefits in some or all of the following primary outcome variables: improvement in postprandial blood glucose, oral glucose tolerance test, fasting insulin, and calculated insulin sensitivity (HOMA) in individuals with prediabetes. Secondary outcome variables are improved markers of inflammation, antioxidant status, blood lipids, blood pressure, and endothelial function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –This arm will receive generalized nutrition therapy throughout the study. Participants will receive dietary recommendations based on their needs and will be educated about the recommended amount of carbohydrates for each meal and the carbohydrate choices. Participants will also be provided with a CGM device; however, participants will be blind to the CGM recordings until the end of the study. |
| Intervention Group | Experimental | Other: Individualized Nutrition TherapyThis arm will receive both individualized nutrition therapy and generalized nutrition therapy throughout the study. Participants will receive dietary recommendations based on their needs and will be educated about the recommended amount of carbohydrates for each meal and the carb choices. Participants will also be provided with a CGM device and will be educated to review their blood glucose measurements and record above range measures along with time, types and amount of food items consumed, cooking method, and any type of physical activity within one hour before or after the meal. This information will be reviewed by one of the research staff at each visit and will be used to set individualized goals for modifying diet and controlling blood glucose. Participants will visit every 10 days for 30 days to conduct measurements, replace their CGM, set new goals based on their food diary and CGM recordings, and receive further dietary recommendations. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ages 45-65 years
- Any race or ethnicity
- Those who have or may have pre-diabetes (will be screened to confirm)
- HbA1c level between 5.7%-6.4% (will be screened to confirm)
- BMI between 25 and 39.9 kg/m2
Key exclusion criteria (12 listed)
- Pregnant or lactating
- Individuals outside of the HbA1c and BMI inclusion ranges
- Those with active cancer, thyroid, kidney, liver, and pancreatic diseases
- Heavy cigarette smokers (25 cigarettes per day or more)
- Heavy drinkers (>12 alcoholic drinks per week on average)
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 |
|---|---|---|
| Individualized Nutrition TherapyExplained in arm/group description. | Other | Intervention Group |
Primary outcome
Change in interstitial glucose concentrations [Time Frame: baseline, 10 days, 20 days, and 30 days]
Time frame: baseline, 10 days, 20 days, and 30 days
Evaluating change in 24hr interstitial glucose concentrations and glycemic variability from baseline measure using a Continuous Glucose Monitoring (CGM) device
Change in insulin sensitivity [Time Frame: baseline, 10 days, 20 days, and 30 days]
Time frame: baseline, 10 days, 20 days, and 30 days
Change in insulin sensitivity from baseline measure will be assessed using the homeostatic model of insulin resistance (HOMA-IR) and insulin secretion (HOMA-β)
Change in glucose tolerance [Time Frame: baseline, 10 days, 20 days, and 30 days]
Time frame: baseline, 10 days, 20 days, and 30 days
Change in glucose tolerance from baseline measures will be assessed using an oral glucose tolerance test
7 secondary outcomes
Change in inflammation status [Time Frame: baseline, 10 days, 20 days, and 30 days]
Time frame: baseline, 10 days, 20 days, and 30 days
Change in lipid profiles [Time Frame: baseline, 10 days, 20 days, and 30 days]
Time frame: baseline, 10 days, 20 days, and 30 days
Change in markers of endothelial function [Time Frame: baseline, 10 days, 20 days, and 30 days]
Time frame: baseline, 10 days, 20 days, and 30 days
Change in blood pressure [Time Frame: baseline, 10 days, 20 days, and 30 days]
Time frame: baseline, 10 days, 20 days, and 30 days
Change in atherogenic risk ratios [Time Frame: baseline, 10 days, 20 days, and 30 days]
Time frame: baseline, 10 days, 20 days, and 30 days
Change in antioxidant status [Time Frame: baseline, 10 days, 20 days, and 30 days]
Time frame: baseline, 10 days, 20 days, and 30 days
Change in dietary intake [Time Frame: baseline, 10 days, 20 days, and 30 days]
Time frame: baseline, 10 days, 20 days, and 30 days
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 8 May 2024.
- Individual participant dataSharing planned: No
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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.
Raedeh Basiri, PhD principal investigator
George Mason University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Nutrition Therapy in people with PreDiabetes and Cardiovascular Diseases, run by George Mason University at 1 site in United States.
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 6 inclusion and 12 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 8 May 2024. 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 United States. 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?
Change in interstitial glucose concentrations [Time Frame: baseline, 10 days, 20 days, and 30 days] (time frame: baseline, 10 days, 20 days, and 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.