HypoglycemiaPhase 1NCT02733848
CREON for the Treatment of Post-RYGB Hypoglycemia
A Phase 1 study testing Creon and Diet in people with Hypoglycemia, run by East Carolina University.
Trial summary
Hypoglycemia is an increasingly recognized complication of Roux-en-Y gastric bypass (RYGB) that is poorly understood and difficult to treat. Investigators hypothesize that after RYGB some patients have incomplete carbohydrate absorption in the small intestine which leads to inconsistent glucose levels and hypoglycemia… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypoglycemia
- What is being tested?
- Creon and Diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to 31 Jan 2018
- Phase
- Phase 1
- 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
- Males and females 18 years and older
- At least 6 months post-RYGB surgery
- Clinical history of post-surgical hypoglycemia evident by subjective symptoms (i.e. tachycardia, sweating, hunger, confusion) and glucose monitoring demonstrating a venous blood sugars < 70 mg/dL
- Women must be postmenopausal, surgically sterile, not heterosexually active or heterosexually active using highly effective method of birth control
- Women of childbearing potential must have negative pregnancy test
- Subjects must have signed an informed consent document indicating they understand the purpose of and procedures required for the study and be willing to participate in the study
- Willing and able to adhere to restrictions and follow instructions specific to this study
- Adequate compliance in performing self-monitoring blood glucose (SMBG) testing at least three or more times per week and taking assigned medication dose as instructed
Who cannot join
- Current or past history of type 1 or type 2 diabetes
- Known hypersensitivity to Creon
- Known hypersensitivity to pork-derived products
- Liver function studies 2 times the upper limit of normal (ALT \& AST) and/or a GFR < 90
- History of fibrosing colonic strictures
- History of gastroparesis, dysphagia, chronic abdominal pain, gastric outlet obstruction, chronic pancreatitis
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- History of stomach, small intestine or colon surgery other than Roux-en-Y gastric bypass
- An active cancer of any type requiring concurrent treatment
- History of gout or hyperuricemia
- Current anemia requiring iron replacement
- Any clinically significant condition that in the opinion of the investigator would make participation not in the best interest or safety of the subject or could prevent limit or confound the specific endpoints assessments
- Not participating in any other research study
- Known history of drug or alcohol abuse within 6 months of screening visit
- Pregnancy or lactation (breastfeeding)
- Informed consent withdrawal by subject
About this study
Official title: A Proof-of-Concept Study Using Pancreatic Enzyme Replacement for the Treatment of Post-Roux-en-Y Gastric Bypass Hypoglycemia
Hypoglycemia is an increasingly recognized complication of Roux-en-Y gastric bypass (RYGB) that is poorly understood and difficult to treat. Investigators hypothesize that after RYGB some patients have incomplete carbohydrate absorption in the small intestine which leads to inconsistent glucose levels and hypoglycemia during oral consumption of a meal. Investigators further hypothesize that pancreatic enzyme supplementation with (Creon) during meals and snacks will improve carbohydrate absorption and lead to more stable glucose levels in patients with post-RYGB hypoglycemia.
Read the detailed description
Primary Objective: Evaluate the feasibility and safety of Creon in the treatment of post-RYGB hypoglycemia as add-on therapy to a diet higher in protein and lower in carbohydrate.
Secondary Objective: Evaluate utility of continuous glucose monitoring (CGM) in monitoring hypoglycemia as an adjunct to standard venous blood testing using a glucometer in post-RYGB hypoglycemia.
- Conditions
- Hypoglycemia
- Being tested
- Creon, Diet, Placebo
- Keywords
- Roux-en-Y gastric bypass, Hypoglycemia, Creon
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CreonDrug
Creon is a porcine derived pancreatic enzyme supplement that comes in in fixed dose combinations of lipase, protease, and amylase, respectively. Dosing is based on lipase per kilograms per meal (i.e. lipase units/kg/meal). Subjects will be started at a dose of 500 units of lipase/kg/meal and snacks at week 4 and continued until week 8. A follow-up visit at week 6 will assess patient for tolerance to Creon and need for dosage adjustment.
Formulations come in different fixed dose combinations as follows:
Creon: Lipase 3000 USP units, protease 9500 USP units, and amylase 15,000 USP units
Creon: Lipase 6000 USP units, protease 19,000 USP units, and amylase 30,000 USP units
Creon: Lipase 12,000 USP units, protease 38,000 USP units, and amylase 60,000 USP units
Creon: Lipase 24,000 USP units, protease 76,000 USP units, and amylase 120,000 USP units
Creon: Lipase 36,000 USP units, protease 114,000 USP units, and amylase 180,000 USP units
DietOther
A registered dietician will meet with the subject and take a thorough review of the patient's dietary history. The subject will then be counseled on a lower carbohydrate and higher protein diet. This diet will be continued for the entire 12 week of the study. The registered dietician will reinforce dietary recommendations by phone on week 2, 4 and 8, respectively.
PlaceboOther
Placebo will be given to the patient in single blind fashion with the subject unaware but PI aware of study drug assignment from week 8-12. Placebo tablets will be given with meals and snacks similar to CREON to maintain patient blinding to study drug assignment. A follow-up visit on week 10 to review patient tolerance, side effects and possible drug adjustment.
| Study group | Role | What they receive |
|---|---|---|
| DIET | Experimental | A registered dietician (RD) will meet with and thoroughly review the patients diet. The patient will be counseled on a diet lower in refined carbohydrates and higher in protein. Receives: Other: Diet |
| Creon | Active comparator | Subjects will be provided Creon at a dose of 500 units/kg of lipase to be taken with meals and snacks to see if this decreases frequency and severity of hypoglycemia. Receives: Drug: Creon |
| Placebo | Placebo comparator | Subjects will be provided placebo and advised to take it with meals and snacks to provide. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Hypoglycemia
The effect of DIET, CREON and PLACEBO on the number of hypoglycemic events (i.e. <70 mg/dl) will be assessed using a standard blood glucose monitor that measures glucose in venous blood.
Measured: 2 years
Secondary outcomes (1)
Continuous Glucose Monitoring using the Medtronic iPro 2
The effect of DIET, CREON and PLACEBO on the percent of time iPro 2 glucose values are less than 70 mg/dL will be measured.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startFeb 2014
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Why it stopped: Lack of funding
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 HypoglycemiaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moahad S Dar, East Carolina University
- Investigators
- Moahad S Dar, MD, Principal investigator, Brody School of Medicine at East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733848
- Sponsor's protocol ID
- UMCIRB 11-001311
- Status last verified
- Oct 2023
- First submitted
- 15 Feb 2016
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Sarwar H, Chapman WH 3rd, Pender JR, Ivanescu A, Drake AJ 3rd, Pories WJ, Dar MS. Hypoglycemia after Roux-en-Y gastric bypass: the BOLD experience. Obes Surg. 2014 Jul;24(7):1120-4. doi: 10.1007/s11695-014-1260-8. No abstract available.
PubMed 24737312
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-Concept Study Using Pancreatic Enzyme Replacement for the Treatment of Post-Roux-en-Y Gastric Bypass Hypoglycemia
- ClinicalTrials.gov ID
- NCT02733848
- Acronym / sponsor ID
- UMCIRB 11-001311
- Conditions
- Hypoglycemia
- Keywords
- Roux-en-Y gastric bypass, Hypoglycemia, Creon
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 12 Apr 2016 (estimated)
- 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.
Hypoglycemia is an increasingly recognized complication of Roux-en-Y gastric bypass (RYGB) that is poorly understood and difficult to treat. Investigators hypothesize that after RYGB some patients have incomplete carbohydrate absorption in the small intestine which leads to inconsistent glucose levels and hypoglycemia during oral consumption of a meal. Investigators further hypothesize that pancreatic enzyme supplementation with (Creon) during meals and snacks will improve carbohydrate absorption and lead to more stable glucose levels in patients with post-RYGB hypoglycemia.
Detailed description
Primary Objective: Evaluate the feasibility and safety of Creon in the treatment of post-RYGB hypoglycemia as add-on therapy to a diet higher in protein and lower in carbohydrate.
Secondary Objective: Evaluate utility of continuous glucose monitoring (CGM) in monitoring hypoglycemia as an adjunct to standard venous blood testing using a glucometer in post-RYGB hypoglycemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DIET | Experimental | Other: DietA registered dietician (RD) will meet with and thoroughly review the patients diet. The patient will be counseled on a diet lower in refined carbohydrates and higher in protein. |
| Creon | Active comparator | Drug: CreonSubjects will be provided Creon at a dose of 500 units/kg of lipase to be taken with meals and snacks to see if this decreases frequency and severity of hypoglycemia. |
| Placebo | Placebo comparator | Other: PlaceboSubjects will be provided placebo and advised to take it with meals and snacks to provide. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females 18 years and older
- At least 6 months post-RYGB surgery
- Clinical history of post-surgical hypoglycemia evident by subjective symptoms (i.e. tachycardia, sweating, hunger, confusion) and glucose monitoring demonstrating a venous blood sugars < 70 mg/dL
- Women must be postmenopausal, surgically sterile, not heterosexually active or heterosexually active using highly effective method of birth control
- Women of childbearing potential must have negative pregnancy test
Key exclusion criteria (15 listed)
- Current or past history of type 1 or type 2 diabetes
- Known hypersensitivity to Creon
- Known hypersensitivity to pork-derived products
- Liver function studies 2 times the upper limit of normal (ALT \& AST) and/or a GFR < 90
- History of fibrosing colonic strictures
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 |
|---|---|---|
| CreonCreon is a porcine derived pancreatic enzyme supplement that comes in in fixed dose combinations of lipase, protease, and amylase, respectively. Dosing is based on lipase per kilograms per meal (i.e. lipase units/kg/meal). Subjects will be started at a dose of 500 units of lipase/kg/meal and snacks at week 4 and continued until week 8. A follow-up visit at week 6 will assess patient for tolerance to Creon and need for dosage adjustment. Formulations come in different fixed dose combinations as follows: Creon: Lipase 3000 USP units, protease 9500 USP units, and amylase 15,000 USP units Creon: Lipase 6000 USP units, protease 19,000 USP units, and amylase 30,000 USP units Creon: Lipase 12,000 USP units, protease 38,000 USP units, and amylase 60,000 USP units Creon: Lipase 24,000 USP units, protease 76,000 USP units, and amylase 120,000 USP units Creon: Lipase 36,000 USP units, protease 114,000 USP units, and amylase 180,000 USP units | Drug | Creon |
| DietA registered dietician will meet with the subject and take a thorough review of the patient's dietary history. The subject will then be counseled on a lower carbohydrate and higher protein diet. This diet will be continued for the entire 12 week of the study. The registered dietician will reinforce dietary recommendations by phone on week 2, 4 and 8, respectively. | Other | DIET |
| PlaceboPlacebo will be given to the patient in single blind fashion with the subject unaware but PI aware of study drug assignment from week 8-12. Placebo tablets will be given with meals and snacks similar to CREON to maintain patient blinding to study drug assignment. A follow-up visit on week 10 to review patient tolerance, side effects and possible drug adjustment. | Other | Placebo |
Primary outcome
Frequency of Hypoglycemia
Time frame: 2 years
The effect of DIET, CREON and PLACEBO on the number of hypoglycemic events (i.e. <70 mg/dl) will be assessed using a standard blood glucose monitor that measures glucose in venous blood.
1 secondary outcome
Continuous Glucose Monitoring using the Medtronic iPro 2
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Background: PubMed 24737312Sarwar H, Chapman WH 3rd, Pender JR, Ivanescu A, Drake AJ 3rd, Pories WJ, Dar MS. Hypoglycemia after Roux-en-Y gastric bypass: the BOLD experience. Obes Surg. 2014 Jul;24(7):1120-4. doi: 10.1007/s11695-014-1260-8. No abstract available.
- Individual participant dataSharing planned: Yes
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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.
Moahad S Dar, MD principal investigator
Brody School of Medicine at East Carolina University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Creon and Diet in people with Hypoglycemia, run by East Carolina University.
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 8 inclusion and 15 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: stopped early, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
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?
Frequency of Hypoglycemia (time frame: 2 years). 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 NCT02733848, 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 26 Oct 2023.