Diabetes Mellitus, Type 2F2GNCT04215328
Facilitated Release of Endogenous Enterokines
A study testing Mixed-Meal and Electrolyte Solution in people with Diabetes Mellitus, Type 2, run by University of Southern California at 1 site in United States.
Trial summary
The overall objective is to develop therapy for obesity and diabetes that is as effective as gastric bypass surgery but without the cost and safety concerns. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Mixed-Meal and Electrolyte Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2014to 28 Feb 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes on oral antidiabetic medication
- BMI greater than or equal to 30kg/m2
- A1C less than 9%
Who cannot join
- Use of any of the following medications: dipeptide-peptidase IV (DPP-IV) inhibitors (e.g., sitagliptin), GLP-1 analogs (e.g., exenatide) or medication that could alter glucose tolerance (e.g. steroids)
- Contraindication to tube (e.g. Prior upper gastrointestinal bleed, or history of easy bleeding, altered foregut anatomy due to obstruction or surgery)
- Known cardiovascular disease other than controlled hypertension.
- Pregnancy or unwilling to take contraception
- Active esophagitis
- Known hiatal hernia
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- Active gastric ulcer and/or duodenal ulcers,
- Previous restrictive surgery of the gastrointestinal tract
- Crohn's disease
- Active cancer
- History of gastrointestinal hemorrhage
- Known upper gastrointestinal lesions with potential to bleed
- Use of NSAIDs or anticoagulants
- Psychiatric disorders other than mild depression
- Likely inability to adhere to study protocol including alcohol or drug dependent patients
- Type I diabetes,
- Liver, kidney or multi-organ dysfunction.
- Known eating disorders
- Inability to attend scheduled or unanticipated study visits
- Known prior abdominal problems or operations that could lead to adhesions or strictures and that could prevent the spontaneous passage of a 10 French jejunal tube if it were to dislodge distally.
Trial locations and contacts
1 site in 1 country.
United States1 site
Roybal Diabetes Management Clinic
Los Angeles, California, 90022
About this study
Official title: Facilitated Release of Endogenous Enterokines: An Ambulatory Prospective Randomized Controlled Trial
The overall objective is to develop therapy for obesity and diabetes that is as effective as gastric bypass surgery but without the cost and safety concerns.
Read the detailed description
Gastric bypass leads to rapid, sustained diabetes remission in the majority of patients who undergo this procedure and is also highly effective therapy for obesity. However, currently <1% of medically-eligible patients undergo this or other bariatric operations due to cost and safety concerns. The approach is based on data suggesting that the benefit of gastric bypass is largely due to anatomical rearrangement of the intestine which leads to accelerated delivery of nutrients to the jejunum. This rerouting of nutrients stimulates the release of multiple neural, hormonal and enterokine responses that are associated with appetite suppression and improved glucose control. In this pilot proposal the question under investigation is whether repeated rapid delivery of a mixed meal directly to the jejunum can promote weight loss and glucose control.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Mixed-Meal, Electrolyte Solution
- Keywords
- Obesity, Diabetes Mellitus, Type 2, Nutrient
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed-MealDietary supplement
Also called Ensure Nutrition Shake® (Abbott Park, Illinois, U.S.A.)
Per 250ml bottle: 220 calories, protein 9g, carbohydrate 33g (15g sugar), fat 6g, sodium 190mg, potassium 390mg; 500mLs by tube daily in 4 doses
Electrolyte SolutionDietary supplement
Also called Unflavored Pedialyte ® (Abbott Park, Illinois, U.S.A.)
Electrolyte Solution 500mLs by tube daily in 4 doses
| Study group | Role | What they receive |
|---|---|---|
| Mixed-Meal | Experimental | Ensure Nutrition Shake Receives: Dietary Supplement: Mixed-Meal |
| Electrolyte Solution | Placebo comparator | Pedialyte Solution Receives: Dietary Supplement: Electrolyte Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change between groups
Weight measured in kilograms taken before and immediately following the intervention period between the intervention and control group
Measured: Day 0 to Day 14
Secondary outcomes (6)
Caloric intake within and between groups
Caloric intake measured in kcal. Determined by consumption of provided food.
Measured: Day 0 to Day 14
Weight change within group
Weight measured in kilgrams. Within group
Measured: Day 0 to Day 14
Change in waist and hip measurements
Measured in centimeters. Between groups.
Measured: Day 0 to Day 14
Change in systolic and diastolic blood pressure
Measured in mmHg for both. Between groups.
Measured: Day 0 to Day 14
Change in heart rate
Measured in beats per minute. Between groups.
Measured: Day 0 to Day 14
Changes in gut hormone levels
Including GLP-1, PYY, CCK, C-peptide, and insulin. Between groups.
Measured: Day 0 to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start1 Nov 2014
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
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.
- More trials run by University of Southern CaliforniaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Halyard Health, Wallace H. Coulter Foundation
- Responsible party
- Principal investigator, Elizabeth Beale, University of Southern California
- Investigators
- Elizabeth Beale, MD, Principal investigator, University of Southern California, Keck School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215328
- Sponsor's protocol ID
- USC HS-13-00748
- Acronym
- F2G
- Status last verified
- Jan 2020
- First submitted
- 26 Dec 2019
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beale EO, Lee W, Lee A, Lee C, Soffer E, Crookes PF, Eagilen K, Chen R, Mack WJ, Tong H. Effect of bolus enteral tube feeding on body weight in ambulatory adults with obesity and type 2 diabetes: a feasibility pilot randomized trial. Nutr Diabetes. 2020 Jun 17;10(1):22. doi: 10.1038/s41387-020-0125-6.
PubMed 32555148
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitated Release of Endogenous Enterokines: An Ambulatory Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04215328
- Acronym / sponsor ID
- F2G / USC HS-13-00748
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Obesity, Diabetes Mellitus, Type 2, Nutrient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Halyard Health, Wallace H. Coulter Foundation
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 2 Jan 2020 (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 objective is to develop therapy for obesity and diabetes that is as effective as gastric bypass surgery but without the cost and safety concerns.
Detailed description
Gastric bypass leads to rapid, sustained diabetes remission in the majority of patients who undergo this procedure and is also highly effective therapy for obesity. However, currently <1% of medically-eligible patients undergo this or other bariatric operations due to cost and safety concerns. The approach is based on data suggesting that the benefit of gastric bypass is largely due to anatomical rearrangement of the intestine which leads to accelerated delivery of nutrients to the jejunum. This rerouting of nutrients stimulates the release of multiple neural, hormonal and enterokine responses that are associated with appetite suppression and improved glucose control. In this pilot proposal the question under investigation is whether repeated rapid delivery of a mixed meal directly to the jejunum can promote weight loss and glucose control.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mixed-Meal | Experimental | Dietary Supplement: Mixed-MealEnsure Nutrition Shake |
| Electrolyte Solution | Placebo comparator | Dietary Supplement: Electrolyte SolutionPedialyte Solution |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes on oral antidiabetic medication
- BMI greater than or equal to 30kg/m2
- A1C less than 9%
Key exclusion criteria (20 listed)
- Use of any of the following medications: dipeptide-peptidase IV (DPP-IV) inhibitors (e.g., sitagliptin), GLP-1 analogs (e.g., exenatide) or medication that could alter glucose tolerance (e.g. steroids)
- Contraindication to tube (e.g. Prior upper gastrointestinal bleed, or history of easy bleeding, altered foregut anatomy due to obstruction or surgery)
- Known cardiovascular disease other than controlled hypertension.
- Pregnancy or unwilling to take contraception
- Active esophagitis
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 |
|---|---|---|
| Mixed-MealAlso: Ensure Nutrition Shake® (Abbott Park, Illinois, U.S.A.)Per 250ml bottle: 220 calories, protein 9g, carbohydrate 33g (15g sugar), fat 6g, sodium 190mg, potassium 390mg; 500mLs by tube daily in 4 doses | Dietary supplement | Mixed-Meal |
| Electrolyte SolutionAlso: Unflavored Pedialyte ® (Abbott Park, Illinois, U.S.A.)Electrolyte Solution 500mLs by tube daily in 4 doses | Dietary supplement | Electrolyte Solution |
Primary outcome
Weight change between groups
Time frame: Day 0 to Day 14
Weight measured in kilograms taken before and immediately following the intervention period between the intervention and control group
6 secondary outcomes
Caloric intake within and between groups
Time frame: Day 0 to Day 14
Weight change within group
Time frame: Day 0 to Day 14
Change in waist and hip measurements
Time frame: Day 0 to Day 14
Change in systolic and diastolic blood pressure
Time frame: Day 0 to Day 14
Change in heart rate
Time frame: Day 0 to Day 14
Changes in gut hormone levels
Time frame: Day 0 to Day 14
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 7 Jan 2020.
- Derived from this study: PubMed 32555148Beale EO, Lee W, Lee A, Lee C, Soffer E, Crookes PF, Eagilen K, Chen R, Mack WJ, Tong H. Effect of bolus enteral tube feeding on body weight in ambulatory adults with obesity and type 2 diabetes: a feasibility pilot randomized trial. Nutr Diabetes. 2020 Jun 17;10(1):22. doi: 10.1038/s41387-020-0125-6.
- 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.
Elizabeth Beale, MD principal investigator
University of Southern California, Keck School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixed-Meal and Electrolyte Solution in people with Diabetes Mellitus, Type 2, run by University of Southern California 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 3 inclusion and 20 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 7 Jan 2020. 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. Some participants in this study may receive a placebo. 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?
Weight change between groups (time frame: Day 0 to Day 14). 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 NCT04215328, 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 7 Jan 2020; AzTrials last refreshed its copy on 2 Nov 2026.