Type 2 DiabetesCB4NCT02815943
Postprandial Metabolism After Bariatric Surgery in Type 2 Diabetes
A study testing biliopancreatic diversion with duodenal switch, sleeve gastrectomy and liquid meal in people with Type 2 Diabetes and Obese, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
Bariatric surgery procedures have now been firmly demonstrated to lead to significant improvement and even, in many cases, complete reversal of abnormal glucose homeostasis in type 2 diabetes (T2D). Various surgery procedures are can be performed to induce weight loss. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Obese
- What is being tested?
- biliopancreatic diversion with duodenal switch, sleeve gastrectomy and liquid meal
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to Dec 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Four groups of 11 subjects each: obese subjects with T2D or with normal glucose tolerance undergoing either BPD-DS or SG for treatment of obesity. T2D and control subjects will be matched for age (± 3 years), BMI (± 2 kg/m2) and gender across both BPD-DS and SG.
Who cannot join
- presence of overt cardiovascular disease, as assessed by history, physical exam, and abnormal EKG;
- treatment with a fibrate, a thiazolidinedione, a beta-blocker or other drugs known to affect lipid or carbohydrate metabolism (except statins, sulfonylurea, metformin, and other antihypertensive agents that can be temporarily stopped prior to the protocols);
- presence of liver or renal disease, uncontrolled thyroid disorder or other major illnesses;
- smoking (>1 cigarette/day) and/or consumption of more than 2 alcoholic beverages per day;
- prior history or current fasting plasma cholesterol level > 7 mmol/l or fasting TG > 6 mmol/l;
- any other contraindication to temporarily stop current medications for hyperglycemia, lipids, or hypertension.
Trial locations and contacts
1 site in 1 country.
About this study
Bariatric surgery procedures have now been firmly demonstrated to lead to significant improvement and even, in many cases, complete reversal of abnormal glucose homeostasis in type 2 diabetes (T2D). Various surgery procedures are can be performed to induce weight loss. The most striking anti-diabetic effects are observed with biliopancreatic diversion with duodenal switch (BPD-DS), followed by Roux-in-Y gastric bypass (RYGB) and sleeve gastrectomy (SG). The first two procedures induce both a restriction of energy intake and a low absorption of dietary fatty acids while the latter exclusively targets energy intake restriction. The investigator and others have shown that improvement of T2D occurs within days after BPD-DS or RYGB in the vast majority of patients, prior to any significant weight loss. This very rapid metabolic recovery is explained by a normalization of β-cell function after meal challenges and ameliorated hepatic insulin sensitivity. The investigator and others have shown that these acute anti-diabetic effects are mostly recapitulated by matched caloric restriction, independent of changes in gastrointestinal hormones, showing the importance of gastrointestinal-derived energy fluxes for acute diabetes control. Muscle insulin sensitivity, on the other hand, improves more slowly in association with weight loss, demonstrating the heterogeneous metabolic response of the various organs to BPD-DS. Some preliminary studies also demonstrate a rapid reduction of NEFA levels and production rate upon i.v. administration of lipids during euglycemic hyperinsulinemic clamps. This very rapid improvement in NEFA tolerance strongly suggests that adipose tissue storage of circulating fatty acids also improves very rapidly, prior to any significant weight loss, after BPD-DS. It may also suggest an acceleration of oxidative fatty acid metabolism in organs such as the liver, the heart and/or skeletal muscles. Studies of the rapid metabolic changes after bariatric surgery conducted thus far rapidly improved the understanding of the fundamental pathogenic defects of T2D. However, much remains to be understood about the acute changes in gastrointestinal-derived metabolic fluxes, organ-specific metabolic responses to bariatric surgery and their relationship with the reversal of T2D. Using in vivo methodological approaches, the investigator proposes to investigate the early organ-specific changes in dietary fatty acid metabolism in response to BPD-DS vs. SG and their relation to improved systemic changes in glucose homeostasis, insulin sensitivity and β-cell function in patients with T2D.
Read the detailed description
Participants will undergo a metabolic study before and 8 to 12 days after bariatric surgery after a 12-hour fast and a three-day food and physical activity diary with accelerometry. The patients recover very rapidly from the surgery and will be able to participate to the proposed investigations the week after their hospitalization on an outpatient basis on the earliest week day between 8 and 12 days after the surgery procedure. The metabolic study is a 6-hour meal test using Positron Emitting Tomography (PET).
- Conditions
- Type 2 Diabetes, Obese
- Being tested
- biliopancreatic diversion with duodenal switch, sleeve gastrectomy, liquid meal, PET/scan, [7,7,8,8-2H]-palmitate
- 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.
biliopancreatic diversion with duodenal switchProcedure or surgery
sleeve gastrectomyProcedure or surgery
liquid mealOther
will be consumed over 30 minutes with [U-13C]-palmitate (0.2 g mixed in the liquid meal) and H2-glucose
PET/scanRadiation
a dynamic and whole body PET acquisition will be performed on a thoraco-abdominal segment, 150 minutes after an oral administration of 18FTHA
[7,7,8,8-2H]-palmitateOther
i.v. administration of [7,7,8,8-2H]-palmitate (in 25% human albumin) from time -60 to 360 min.
indirect calorimetryDevice
will be performed every hour throughout the protocol along with exhaled breath collection
| Study group | Role | What they receive |
|---|---|---|
| Before DBP-DS surgery | Other | Not described Receives: Other: liquid meal; Radiation: PET/scan; Other: [7,7,8,8-2H]-palmitate; Device: indirect calorimetry |
| After DBP-DS surgery | Experimental | It is a bariatric surgery. BPD consists in the exclusion of the duodenum from the alimentary tract with re-anastomosis of the blind loop 100 to 150 cm proximal to the ileo-coecal valve. This leads to bypass of the biliopancreatic secretions towards the distal small intestine, resulting in fat malabsorption. BPD also entails a distal gastrectomy to avoid the occurrence of peptic ulceration of the gastrointestinal anastomosis. Receives: Procedure: biliopancreatic diversion with duodenal switch; Other: liquid meal; Radiation: PET/scan; Other: [7,7,8,8-2H]-palmitate; Device: indirect calorimetry |
| Before SG surgery | Other | Not described Receives: Other: liquid meal; Radiation: PET/scan; Other: [7,7,8,8-2H]-palmitate; Device: indirect calorimetry |
| After SG surgery | Experimental | It is a bariatric surgery where the stomach is reduced to about 15% of its original size, by surgical removal of a large portion of the stomach along the greater curvature. Receives: Procedure: sleeve gastrectomy; Other: liquid meal; Radiation: PET/scan; Other: [7,7,8,8-2H]-palmitate; Device: indirect calorimetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose metabolism
will be determined using tracers of glucose
Measured: 2 years
dietary fatty acid uptake
assessed using PET/CT method with oral administration of 18FTHA
Measured: 2 years
whole body inter-organ partitioning
assessed using PET/CT method with oral administration of 18FTHA
Measured: 2 years
lipid metabolism
will be determined using tracers of fatty acids
Measured: 2 years
Secondary outcomes (7)
Dietary fatty acid oxidation rate
will be measured using breath 13CO2 enrichment
Measured: 2 years
Total oxidation rate
will be determined by indirect calorimetry
Measured: 2 years
Hormonal responses
will be determined using a multiplex assay system.
Measured: 2 years
Insulin sensitivity
will be determined using different standard methods, including the HOMA-IR
Measured: 2 years
Insulin secretion index (ISI)
will be assessed using deconvolution of plasma C-peptide with standard C-peptide kinetic parameters
Measured: 2 years
habitual food intake
with a 3-day food record,
Measured: 2 years
physical activity
with portable arm band accelerometry for 3 days prior to each metabolic study
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 posted28 Jun 2016 (estimated)
- Study startAug 2015
- Primary completionDec 2019
- Study completionDec 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 Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Laval University
- Responsible party
- Principal investigator, André Carpentier, Université de Sherbrooke
- Investigators
- André Carpentier, MD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815943
- Sponsor's protocol ID
- 2015-901, 14-176
- Acronym
- CB4
- Status last verified
- May 2022
- First submitted
- 23 Jun 2016
- Last updated
- 17 May 2022
- Results posted
- No
Publications
Carreau AM, Noll C, Blondin DP, Frisch F, Nadeau M, Pelletier M, Phoenix S, Cunnane SC, Guerin B, Turcotte EE, Lebel S, Biertho L, Tchernof A, Carpentier AC. Bariatric Surgery Rapidly Decreases Cardiac Dietary Fatty Acid Partitioning and Hepatic Insulin Resistance Through Increased Intra-abdominal Adipose Tissue Storage and Reduced Spillover in Type 2 Diabetes. Diabetes. 2020 Apr;69(4):567-577. doi: 10.2337/db19-0773. Epub 2020 Jan 8.
PubMed 31915151
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Metabolism After Bariatric Surgery in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02815943
- Acronym / sponsor ID
- CB4 / 2015-901, 14-176
- Conditions
- Type 2 Diabetes, Obese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Laval University
- Study start
- Aug 2015
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 28 Jun 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.
Bariatric surgery procedures have now been firmly demonstrated to lead to significant improvement and even, in many cases, complete reversal of abnormal glucose homeostasis in type 2 diabetes (T2D). Various surgery procedures are can be performed to induce weight loss. The most striking anti-diabetic effects are observed with biliopancreatic diversion with duodenal switch (BPD-DS), followed by Roux-in-Y gastric bypass (RYGB) and sleeve gastrectomy (SG). The first two procedures induce both a restriction of energy intake and a low absorption of dietary fatty acids while the latter exclusively targets energy intake restriction. The investigator and others have shown that improvement of T2D occurs within days after BPD-DS or RYGB in the vast majority of patients, prior to any significant weight loss. This very rapid metabolic recovery is explained by a normalization of β-cell function after meal challenges and ameliorated hepatic insulin sensitivity. The investigator and others have shown that these acute anti-diabetic effects are mostly recapitulated by matched caloric restriction, independent of changes in gastrointestinal hormones, showing the importance of gastrointestinal-derived energy fluxes for acute diabetes control. Muscle insulin sensitivity, on the other hand, improves more slowly in association with weight loss, demonstrating the heterogeneous metabolic response of the various organs to BPD-DS. Some preliminary studies also demonstrate a rapid reduction of NEFA levels and production rate upon i.v. administration of lipids during euglycemic hyperinsulinemic clamps. This very rapid improvement in NEFA tolerance strongly suggests that adipose tissue storage of circulating fatty acids also improves very rapidly, prior to any significant weight loss, after BPD-DS. It may also suggest an acceleration of oxidative fatty acid metabolism in organs such as the liver, the heart and/or skeletal muscles. Studies of the rapid metabolic changes after bariatric surgery conducted thus far rapidly improved the understanding of the fundamental pathogenic defects of T2D. However, much remains to be understood about the acute changes in gastrointestinal-derived metabolic fluxes, organ-specific metabolic responses to bariatric surgery and their relationship with the reversal of T2D. Using in vivo methodological approaches, the investigator proposes to investigate the early organ-specific changes in dietary fatty acid metabolism in response to BPD-DS vs. SG and their relation to improved systemic changes in glucose homeostasis, insulin sensitivity and β-cell function in patients with T2D.
Detailed description
Participants will undergo a metabolic study before and 8 to 12 days after bariatric surgery after a 12-hour fast and a three-day food and physical activity diary with accelerometry. The patients recover very rapidly from the surgery and will be able to participate to the proposed investigations the week after their hospitalization on an outpatient basis on the earliest week day between 8 and 12 days after the surgery procedure. The metabolic study is a 6-hour meal test using Positron Emitting Tomography (PET).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Before DBP-DS surgery | Other | Other: liquid meal, Radiation: PET/scan, Other: [7,7,8,8-2H]-palmitate, Device: indirect calorimetry |
| After DBP-DS surgery | Experimental | Procedure: biliopancreatic diversion with duodenal switch, Other: liquid meal, Radiation: PET/scan, Other: [7,7,8,8-2H]-palmitate, Device: indirect calorimetryIt is a bariatric surgery. BPD consists in the exclusion of the duodenum from the alimentary tract with re-anastomosis of the blind loop 100 to 150 cm proximal to the ileo-coecal valve. This leads to bypass of the biliopancreatic secretions towards the distal small intestine, resulting in fat malabsorption. BPD also entails a distal gastrectomy to avoid the occurrence of peptic ulceration of the gastrointestinal anastomosis. |
| Before SG surgery | Other | Other: liquid meal, Radiation: PET/scan, Other: [7,7,8,8-2H]-palmitate, Device: indirect calorimetry |
| After SG surgery | Experimental | Procedure: sleeve gastrectomy, Other: liquid meal, Radiation: PET/scan, Other: [7,7,8,8-2H]-palmitate, Device: indirect calorimetryIt is a bariatric surgery where the stomach is reduced to about 15% of its original size, by surgical removal of a large portion of the stomach along the greater curvature. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Four groups of 11 subjects each: obese subjects with T2D or with normal glucose tolerance undergoing either BPD-DS or SG for treatment of obesity. T2D and control subjects will be matched for age (± 3 years), BMI (± 2 kg/m2) and gender across both BPD-DS and SG.
Key exclusion criteria (6 listed)
- presence of overt cardiovascular disease, as assessed by history, physical exam, and abnormal EKG;
- treatment with a fibrate, a thiazolidinedione, a beta-blocker or other drugs known to affect lipid or carbohydrate metabolism (except statins, sulfonylurea, metformin, and other antihypertensive agents that can be temporarily stopped prior to the protocols);
- presence of liver or renal disease, uncontrolled thyroid disorder or other major illnesses;
- smoking (>1 cigarette/day) and/or consumption of more than 2 alcoholic beverages per day;
- prior history or current fasting plasma cholesterol level > 7 mmol/l or fasting TG > 6 mmol/l;
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 |
|---|---|---|
| biliopancreatic diversion with duodenal switch | Procedure or surgery | After DBP-DS surgery |
| sleeve gastrectomy | Procedure or surgery | After SG surgery |
| liquid mealwill be consumed over 30 minutes with [U-13C]-palmitate (0.2 g mixed in the liquid meal) and H2-glucose | Other | After DBP-DS surgery, After SG surgery, Before DBP-DS surgery, Before SG surgery |
| PET/scana dynamic and whole body PET acquisition will be performed on a thoraco-abdominal segment, 150 minutes after an oral administration of 18FTHA | Radiation | After DBP-DS surgery, After SG surgery, Before DBP-DS surgery, Before SG surgery |
| [7,7,8,8-2H]-palmitatei.v. administration of [7,7,8,8-2H]-palmitate (in 25% human albumin) from time -60 to 360 min. | Other | After DBP-DS surgery, After SG surgery, Before DBP-DS surgery, Before SG surgery |
| indirect calorimetrywill be performed every hour throughout the protocol along with exhaled breath collection | Device | After DBP-DS surgery, After SG surgery, Before DBP-DS surgery, Before SG surgery |
Primary outcome
glucose metabolism
Time frame: 2 years
will be determined using tracers of glucose
dietary fatty acid uptake
Time frame: 2 years
assessed using PET/CT method with oral administration of 18FTHA
whole body inter-organ partitioning
Time frame: 2 years
assessed using PET/CT method with oral administration of 18FTHA
lipid metabolism
Time frame: 2 years
will be determined using tracers of fatty acids
7 secondary outcomes
Dietary fatty acid oxidation rate
Time frame: 2 years
Total oxidation rate
Time frame: 2 years
Hormonal responses
Time frame: 2 years
Insulin sensitivity
Time frame: 2 years
Insulin secretion index (ISI)
Time frame: 2 years
habitual food intake
Time frame: 2 years
physical activity
Time frame: 2 years
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 17 May 2022.
- Derived from this study: PubMed 31915151Carreau AM, Noll C, Blondin DP, Frisch F, Nadeau M, Pelletier M, Phoenix S, Cunnane SC, Guerin B, Turcotte EE, Lebel S, Biertho L, Tchernof A, Carpentier AC. Bariatric Surgery Rapidly Decreases Cardiac Dietary Fatty Acid Partitioning and Hepatic Insulin Resistance Through Increased Intra-abdominal Adipose Tissue Storage and Reduced Spillover in Type 2 Diabetes. Diabetes. 2020 Apr;69(4):567-577. doi: 10.2337/db19-0773. Epub 2020 Jan 8.
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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.
André Carpentier, MD principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biliopancreatic diversion with duodenal switch, sleeve gastrectomy and liquid meal in people with Type 2 Diabetes and Obese, run by Université de Sherbrooke at 1 site in Canada.
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 1 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 17 May 2022. 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 Canada. 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?
glucose metabolism (time frame: 2 years). The study lists 4 primary outcomes in all. 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 NCT02815943, 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 17 May 2022.