ObesityNCT03536364
Effect of Food Order on Postprandial Glucose Excursions in Pre-Diabetes
A study testing Food Order, Carbohydrate Last and Vegetables first in people with Obesity and Pre-Diabetes, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The natural history of type 2 diabetes commonly follows a pattern of postprandial dysregulation followed by fasting hyperglycemia leading to overt type 2 diabetes. Approximately 38% of the US adult population is estimated to have pre-diabetes. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Obesity, Pre-Diabetes
- What is being tested?
- Food Order, Carbohydrate Last and Vegetables first
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 1 Dec 2017
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects between 30-65 years of age
- BMI 25-40kg/m2
- HbA1c 5.7%-6.4%
- Willing to comply with study requirements
- Provide written informed consent
Who cannot join
- Known diagnosis of diabetes / taking any medication for treatment of diabetes
- History of previous bariatric surgery
- History of chronic liver or renal disease
- Current treatment with systemic corticosteroids
- Pregnant women
- History of allergy to any component of the test meal
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Weight Control Center
New York, New York, 10065
About this study
The natural history of type 2 diabetes commonly follows a pattern of postprandial dysregulation followed by fasting hyperglycemia leading to overt type 2 diabetes. Approximately 38% of the US adult population is estimated to have pre-diabetes. In a previous study of 16 overweight/obese patients with metformin treated type 2 diabetes, using a typical Western meal, investigators demonstrated that a food order in which protein and vegetables are consumed first, before carbohydrate, results in significant lowering of incremental glucose peaks compared to the reverse order. In the present study, investigators seek to expand on the previous findings to gain further insight into the impact of food order in individuals with pre-diabetes, using a meal with different macronutrient composition, in the setting of three meal patterns. The study is designed to be a simple, practical intervention that may have very significant clinical implications for prevention of diabetes in a large population at increased metabolic risk.
- Conditions
- Obesity, Pre-Diabetes
- Being tested
- Food Order, Carbohydrate Last, Vegetables first
- Medical subject headings
- Obesity, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food OrderBehavioural
Also called Carbohydrate First
carbohydrate (ciabatta bread ) first, followed 10 minutes later by protein (grilled chicken) and vegetables
Carbohydrate LastBehavioural
protein and vegetables first, followed 10 minutes later by carbohydrate
Vegetables firstBehavioural
vegetables first, followed 10 mins later by protein and carbohydrate.
| Study group | Role | What they receive |
|---|---|---|
| Prediabetes | Experimental | manipulation of food order during a meal on postprandial in subjects with prediabetes Receives: Behavioral: Food Order; Behavioral: Carbohydrate Last; Behavioral: Vegetables first |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of food order on postprandial glucose excursions as measured by incremental glucose peaks (mg/dl) in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes
Measured: 30, 60, 90, 120, 150 and 180 mins
Effect of food order on postprandial glucose excursions as measured by post prandial glucose levels (mg/dl) in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes
Measured: 30, 60, 90, 120, 150 and 180 mins
Effect of food order on postprandial glucose excursions as measured by incremental area under the curve (iAUC) for glucose ((mg/dl)*180) in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes
Measured: 0-180 min
Secondary outcomes (3)
Effect of food order on postprandial insulin levels (microIU/ml) in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes
Measured: 30, 60, 90, 120, 150 and 180 mins
Effect of food order on postprandial insulin incremental area ((microIU/ml)*180min) under the curve in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes
Measured: 0-180 mins
Effect of food order on satiety as measured by a visual analog scale (cm) in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes
Measured: 0,60,120, and 180 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start1 Mar 2017
- Primary completion1 Oct 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alpana P Shukla, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536364
- Sponsor's protocol ID
- 1612017822
- Status last verified
- May 2018
- First submitted
- 23 Mar 2018
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Food Order on Postprandial Glucose Excursions in Pre-Diabetes
- ClinicalTrials.gov ID
- NCT03536364
- Acronym / sponsor ID
- 1612017822
- Conditions
- Obesity, Pre-Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 24 May 2018 (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 natural history of type 2 diabetes commonly follows a pattern of postprandial dysregulation followed by fasting hyperglycemia leading to overt type 2 diabetes. Approximately 38% of the US adult population is estimated to have pre-diabetes. In a previous study of 16 overweight/obese patients with metformin treated type 2 diabetes, using a typical Western meal, investigators demonstrated that a food order in which protein and vegetables are consumed first, before carbohydrate, results in significant lowering of incremental glucose peaks compared to the reverse order. In the present study, investigators seek to expand on the previous findings to gain further insight into the impact of food order in individuals with pre-diabetes, using a meal with different macronutrient composition, in the setting of three meal patterns. The study is designed to be a simple, practical intervention that may have very significant clinical implications for prevention of diabetes in a large population at increased metabolic risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prediabetes | Experimental | Behavioral: Food Order, Behavioral: Carbohydrate Last, Behavioral: Vegetables firstmanipulation of food order during a meal on postprandial in subjects with prediabetes |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects between 30-65 years of age
- BMI 25-40kg/m2
- HbA1c 5.7%-6.4%
- Willing to comply with study requirements
- Provide written informed consent
Key exclusion criteria (6 listed)
- Known diagnosis of diabetes / taking any medication for treatment of diabetes
- History of previous bariatric surgery
- History of chronic liver or renal disease
- Current treatment with systemic corticosteroids
- Pregnant women
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 |
|---|---|---|
| Food OrderAlso: Carbohydrate Firstcarbohydrate (ciabatta bread ) first, followed 10 minutes later by protein (grilled chicken) and vegetables | Behavioural | Prediabetes |
| Carbohydrate Lastprotein and vegetables first, followed 10 minutes later by carbohydrate | Behavioural | Prediabetes |
| Vegetables firstvegetables first, followed 10 mins later by protein and carbohydrate. | Behavioural | Prediabetes |
Primary outcome
Effect of food order on postprandial glucose excursions as measured by incremental glucose peaks (mg/dl) in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes
Time frame: 30, 60, 90, 120, 150 and 180 mins
Effect of food order on postprandial glucose excursions as measured by post prandial glucose levels (mg/dl) in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes
Time frame: 30, 60, 90, 120, 150 and 180 mins
Effect of food order on postprandial glucose excursions as measured by incremental area under the curve (iAUC) for glucose ((mg/dl)*180) in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes
Time frame: 0-180 min
3 secondary outcomes
Effect of food order on postprandial insulin levels (microIU/ml) in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes
Time frame: 30, 60, 90, 120, 150 and 180 mins
Effect of food order on postprandial insulin incremental area ((microIU/ml)*180min) under the curve in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes
Time frame: 0-180 mins
Effect of food order on satiety as measured by a visual analog scale (cm) in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes
Time frame: 0,60,120, and 180 mins
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 24 May 2018.
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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.
Alpana P Shukla, MD principal investigator
Weill Medical College of Cornell 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 Food Order, Carbohydrate Last and Vegetables first in people with Obesity and Pre-Diabetes, run by Weill Medical College of Cornell 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 5 inclusion and 6 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 24 May 2018. 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?
Effect of food order on postprandial glucose excursions as measured by incremental glucose peaks (mg/dl) in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes (time frame: 30, 60, 90, 120, 150 and 180 mins). 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 24 May 2018.