Impaired Glucose ToleranceAGL11NCT02808182
Postprandial Fatty Acid Metabolism in the Natural History of Type 2 Diabetes (T2D)
A study testing Nicotinic acid, [7,7,8,8-2H]-palmitate and [U-13C]-palmitate in people with Impaired Glucose Tolerance, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
Lipotoxicity-causing fatty acid overexposure and accretion in lean tissues leads to insulin resistance and impaired pancreatic β-cell function - the hallmarks of T2D - contributing to associated complications such as heart failure, kidney failure and microvascular diseases. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Impaired Glucose Tolerance
- What is being tested?
- Nicotinic acid, [7,7,8,8-2H]-palmitate and [U-13C]-palmitate
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jan 2017to May 2021
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For healthy subjects: fasting glucose < 5.6, 2-hour post 75g Oral Glucose Tolerance Test (OGTT) glucose < 7.8 mmol/l and HbA1c < 5.8%
- For subject with glucose intolerance (IGT): 2-hour post 75g OGTT glucose at 7.8-11.1 mmol/l on two separate occasions and HbA1c of 6.0 to 6.4%
Who cannot join
- overt cardiovascular disease as assessed by medical history, physical exam, and abnormal ECG
- treatment with a fibrate, thiazolidinedione, beta-blocker or other drug known to affect lipid or carbohydrate metabolism (except statins, metformin, and other antihypertensive agents that can be safely interrupted)
- presence of liver or renal disease, uncontrolled thyroid disorder, previous pancreatitis, bleeding disorder, or other major illness
- smoking (>1 cigarette/day) and/or consumption of >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 interrupt current meds for lipids or hypertension
- being pregnant
- not be barren
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postprandial Fatty Acid Metabolism in the Natural History of Type 2 Diabetes (T2D): Relative Contribution of Dietary vs Systemic Fatty Acids to Lean Tissue Fatty Acid Fluxes and Oxidative vs Non-oxidative Pathways
Lipotoxicity-causing fatty acid overexposure and accretion in lean tissues leads to insulin resistance and impaired pancreatic β-cell function - the hallmarks of T2D - contributing to associated complications such as heart failure, kidney failure and microvascular diseases. Proper dietary fatty acid (DFA) storage in white adipose tissue (WAT) is now thought to prevent lean-tissue lipotoxicity. Using novel Positron-Emission Tomography (PET) and stable isotopic tracer methods which were developed in Sherbrooke, the investigator showed that WAT storage of DFA is impaired in people with pre-diabetes or T2D. The investigator also showed that this impairment is associated with greater cardiac DFA uptake, as well as subclinical left-ventricular systolic and diastolic dysfunction. Then, It has been found that modest weight loss in pre-diabetics, after a one-year lifestyle intervention, improved WAT DFA storage, curbed cardiac DFA uptake, and restored associated left-ventricular dysfunction. It has been also found that a 7-day low-saturated fat, low-calorie diet raised insulin sensitivity but did not restore WAT or cardiac DFA metabolism. Whether WAT DFA storage directly impacts cardiac DFA uptake is not known. Importantly, the investigator recently uncovered marked sex-specific differences in WAT DFA metabolism. These may explain, at least in part, sex-related differences in the cardiac DFA uptake, which occurs in pre-diabetes. Higher spillover of WAT DFA into circulating Non-Esterified Fatty Acid (NEFA) appears to be linked in women to greater cardiac DFA uptake, as opposed to direct cardiac chylomicron triglycerides (TG) uptake in men. Here, the investigator will isolate and compare organ-specific fatty acid uptake occurring postprandially from chylomicron-TG vs. NEFA pools, as well as the oxidative vs. non-oxidative intracellular metabolic pathways associated with increased cardiac DFA uptake in pre-diabetic men and women.
- Conditions
- Impaired Glucose Tolerance
- Being tested
- Nicotinic acid, [7,7,8,8-2H]-palmitate, [U-13C]-palmitate, Biopsy, liquid meal
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinic acidDrug
Also called Niacin
oral administration of nicotinic acid (100mg at 0, 30, 60, 90, 120, 180, 240 and 300 min) to minimize WAT intracellular lipolysis
[7,7,8,8-2H]-palmitateOther
using i.v. administration of [7,7,8,8-2H]-palmitate (in 25% human albumin) from time -60 to +360 min
[U-13C]-palmitateOther
oral administration of [U-13C]-palmitate (0.2 g mixed into the liquid meal) at time 0 min
BiopsyProcedure or surgery
A subcutaneous abdominal 0.5-g adipose tissue biopsy will be performed at the end of protocols A0 and A1
liquid mealOther
At time 0, a standard liquid meal (400 mL, 906 kcal, 33g-fat/34g-protein/101g-carbohydrates i.e. 33%/17%/50% calories) will be drunk over 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| A0: PET/scan with [11C] palmitate | Other | A bolus of 180 MBq of [11C]-acetate at time 90min and PET acquisition Receives: Procedure: Biopsy; Other: liquid meal |
| A1: PET/scan with [11C] palmitate | Other | A bolus injection of 180 MBq of [11C]-acetate at time 90min, followed by PET acquisition Receives: Drug: Nicotinic acid; Procedure: Biopsy; Other: liquid meal |
| B0: PET/scan with [18F]-FTHA | Other | At time 0, a standard liquid meal will be drunk over 20 minutes with 70 MBq of 18FTHA . PET acquisition at time 90 min. Receives: Other: [7,7,8,8-2H]-palmitate; Other: [U-13C]-palmitate; Other: liquid meal |
| B1: PET/scan with [18F]-FTHA | Other | At time 0, a standard liquid meal will be drunk over 20 minutes with 70 MBq of 18FTHA followed by a PET acquisition at time 90 min. Receives: Drug: Nicotinic acid; Other: [7,7,8,8-2H]-palmitate; Other: [U-13C]-palmitate; Other: liquid meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma NEFA appearance rate
NEFA appearance will be measured using i.v. administration of [7,7,8,8-2H]-palmitate (in 25% human albumin) from time -60 to +360 min, as slightly modified from previous descriptions, using Steele's non steady-state equations. Blood samples to measure plasma palmitate, oleate, linoleate, and total NEFA levels, [7,7,8,8-2H]-palmitate enrichments by GC/MS-MS.
Measured: 2 years
Cardiac and hepatic uptake
will be determined using 11C-palmitate PET/CT. 180 MBq will be administered by bolus injection at postprandial time 90min. After a transmission scan and regional CT (40mA), a 30-min dynamic list-mode PET acquisition will be performed starting at time 90 min on a 18 cm-high thoraco-abdominal segment to include the left cardiac ventricle and most of the liver on a Philips Gemini TOF PET/CT
Measured: 2 years
WAT spillover NEFA appearance rates
WAT spillover NEFA will be determined from oral administration of [U-13C]-palmitate.
Blood samples to measure plasma [U-13C]-palmitate and chylomicron-TG [U-13C]-palmitate enrichment by GC/MS-MS
Measured: 2 years
oxidative metabolism of NEFA
will be assessed by using 13C-palmitate
Measured: 2 years
cardiac and hepatic DFA uptake
will be assessed using PET/CT method with oral administration of 18FTHA
Measured: 2 years
whole-body organ-specific DFA partitioning
will be determined by whole-body CT (16 mA) followed by PET acquisition of 18FTHA
Measured: 2 years
Secondary outcomes (6)
Insulin sensitivity
will be determined using the HOMA-IR (based on fasting insulin and glucose levels)
Measured: 2 years
Insulin secretion rate
will be assessed using deconvolution of plasma C-peptide with standard C-peptide kinetic parameters
Measured: 2 years
β-cell function
will be assessed by calculation of the disposition index (DI) that is insulin secretion in response to the ambient insulin
Measured: 2 years
WAT size
by biopsy fixed in formalin
Measured: 2 years
hormonal response
will be determined using a multiplex assay system
Measured: 2 years
Lipoprotein lipase activity
will be assessed as on frozen 150-mg portions from biopsy
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 posted21 Jun 2016 (estimated)
- Study start17 Jan 2017
- Primary completionDec 2020
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Impaired Glucose ToleranceStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, André Carpentier, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808182
- Sponsor's protocol ID
- 2016-1196
- Acronym
- AGL11
- Status last verified
- Jan 2025
- First submitted
- 14 Apr 2016
- Last updated
- 27 Jan 2025
- Results posted
- No
Publications
Montastier E, Ye RZ, Noll C, Amrani M, Frisch F, Fortin M, Bouffard L, Phoenix S, Sarrhini O, Cunnane SC, Guerin B, Turcotte EE, Carpentier AC. Nicotinic acid increases adipose tissue dietary fatty acid trapping and reduces postprandial hepatic and cardiac fatty acid uptake in prediabetes. Eur J Pharmacol. 2025 Jul 5;998:177563. doi: 10.1016/j.ejphar.2025.177563. Epub 2025 Mar 27.
PubMed 40157702Ye RZ, Montastier E, Noll C, Frisch F, Fortin M, Bouffard L, Phoenix S, Guerin B, Turcotte EE, Carpentier AC. Total Postprandial Hepatic Nonesterified and Dietary Fatty Acid Uptake Is Increased and Insufficiently Curbed by Adipose Tissue Fatty Acid Trapping in Prediabetes With Overweight. Diabetes. 2022 Sep 1;71(9):1891-1901. doi: 10.2337/db21-1097.
PubMed 35748318Montastier E, Ye RZ, Noll C, Bouffard L, Fortin M, Frisch F, Phoenix S, Guerin B, Turcotte EE, Lewis GF, Carpentier AC. Increased postprandial nonesterified fatty acid efflux from adipose tissue in prediabetes is offset by enhanced dietary fatty acid adipose trapping. Am J Physiol Endocrinol Metab. 2021 Jun 1;320(6):E1093-E1106. doi: 10.1152/ajpendo.00619.2020. Epub 2021 Apr 19.
PubMed 33870714
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Fatty Acid Metabolism in the Natural History of Type 2 Diabetes (T2D): Relative Contribution of Dietary vs Systemic Fatty Acids to Lean Tissue Fatty Acid Fluxes and Oxidative vs Non-oxidative Pathways
- ClinicalTrials.gov ID
- NCT02808182
- Acronym / sponsor ID
- AGL11 / 2016-1196
- Conditions
- Impaired Glucose Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 21 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.
Lipotoxicity-causing fatty acid overexposure and accretion in lean tissues leads to insulin resistance and impaired pancreatic β-cell function - the hallmarks of T2D - contributing to associated complications such as heart failure, kidney failure and microvascular diseases. Proper dietary fatty acid (DFA) storage in white adipose tissue (WAT) is now thought to prevent lean-tissue lipotoxicity. Using novel Positron-Emission Tomography (PET) and stable isotopic tracer methods which were developed in Sherbrooke, the investigator showed that WAT storage of DFA is impaired in people with pre-diabetes or T2D. The investigator also showed that this impairment is associated with greater cardiac DFA uptake, as well as subclinical left-ventricular systolic and diastolic dysfunction. Then, It has been found that modest weight loss in pre-diabetics, after a one-year lifestyle intervention, improved WAT DFA storage, curbed cardiac DFA uptake, and restored associated left-ventricular dysfunction. It has been also found that a 7-day low-saturated fat, low-calorie diet raised insulin sensitivity but did not restore WAT or cardiac DFA metabolism. Whether WAT DFA storage directly impacts cardiac DFA uptake is not known. Importantly, the investigator recently uncovered marked sex-specific differences in WAT DFA metabolism. These may explain, at least in part, sex-related differences in the cardiac DFA uptake, which occurs in pre-diabetes. Higher spillover of WAT DFA into circulating Non-Esterified Fatty Acid (NEFA) appears to be linked in women to greater cardiac DFA uptake, as opposed to direct cardiac chylomicron triglycerides (TG) uptake in men. Here, the investigator will isolate and compare organ-specific fatty acid uptake occurring postprandially from chylomicron-TG vs. NEFA pools, as well as the oxidative vs. non-oxidative intracellular metabolic pathways associated with increased cardiac DFA uptake in pre-diabetic men and women.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A0: PET/scan with [11C] palmitate | Other | Procedure: Biopsy, Other: liquid mealA bolus of 180 MBq of [11C]-acetate at time 90min and PET acquisition |
| A1: PET/scan with [11C] palmitate | Other | Drug: Nicotinic acid, Procedure: Biopsy, Other: liquid mealA bolus injection of 180 MBq of [11C]-acetate at time 90min, followed by PET acquisition |
| B0: PET/scan with [18F]-FTHA | Other | Other: [7,7,8,8-2H]-palmitate, Other: [U-13C]-palmitate, Other: liquid mealAt time 0, a standard liquid meal will be drunk over 20 minutes with 70 MBq of 18FTHA . PET acquisition at time 90 min. |
| B1: PET/scan with [18F]-FTHA | Other | Drug: Nicotinic acid, Other: [7,7,8,8-2H]-palmitate, Other: [U-13C]-palmitate, Other: liquid mealAt time 0, a standard liquid meal will be drunk over 20 minutes with 70 MBq of 18FTHA followed by a PET acquisition at time 90 min. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- For healthy subjects: fasting glucose < 5.6, 2-hour post 75g Oral Glucose Tolerance Test (OGTT) glucose < 7.8 mmol/l and HbA1c < 5.8%
- For subject with glucose intolerance (IGT): 2-hour post 75g OGTT glucose at 7.8-11.1 mmol/l on two separate occasions and HbA1c of 6.0 to 6.4%
Key exclusion criteria (8 listed)
- overt cardiovascular disease as assessed by medical history, physical exam, and abnormal ECG
- treatment with a fibrate, thiazolidinedione, beta-blocker or other drug known to affect lipid or carbohydrate metabolism (except statins, metformin, and other antihypertensive agents that can be safely interrupted)
- presence of liver or renal disease, uncontrolled thyroid disorder, previous pancreatitis, bleeding disorder, or other major illness
- smoking (>1 cigarette/day) and/or consumption of >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 |
|---|---|---|
| Nicotinic acidAlso: Niacinoral administration of nicotinic acid (100mg at 0, 30, 60, 90, 120, 180, 240 and 300 min) to minimize WAT intracellular lipolysis | Drug | A1: PET/scan with [11C] palmitate, B1: PET/scan with [18F]-FTHA |
| [7,7,8,8-2H]-palmitateusing i.v. administration of [7,7,8,8-2H]-palmitate (in 25% human albumin) from time -60 to +360 min | Other | B0: PET/scan with [18F]-FTHA, B1: PET/scan with [18F]-FTHA |
| [U-13C]-palmitateoral administration of [U-13C]-palmitate (0.2 g mixed into the liquid meal) at time 0 min | Other | B0: PET/scan with [18F]-FTHA, B1: PET/scan with [18F]-FTHA |
| BiopsyA subcutaneous abdominal 0.5-g adipose tissue biopsy will be performed at the end of protocols A0 and A1 | Procedure or surgery | A0: PET/scan with [11C] palmitate, A1: PET/scan with [11C] palmitate |
| liquid mealAt time 0, a standard liquid meal (400 mL, 906 kcal, 33g-fat/34g-protein/101g-carbohydrates i.e. 33%/17%/50% calories) will be drunk over 20 minutes | Other | A0: PET/scan with [11C] palmitate, A1: PET/scan with [11C] palmitate, B0: PET/scan with [18F]-FTHA, B1: PET/scan with [18F]-FTHA |
Primary outcome
Plasma NEFA appearance rate
Time frame: 2 years
NEFA appearance will be measured using i.v. administration of [7,7,8,8-2H]-palmitate (in 25% human albumin) from time -60 to +360 min, as slightly modified from previous descriptions, using Steele's non steady-state equations. Blood samples to measure plasma palmitate, oleate, linoleate, and total NEFA levels, [7,7,8,8-2H]-palmitate enrichments by GC/MS-MS.
Cardiac and hepatic uptake
Time frame: 2 years
will be determined using 11C-palmitate PET/CT. 180 MBq will be administered by bolus injection at postprandial time 90min. After a transmission scan and regional CT (40mA), a 30-min dynamic list-mode PET acquisition will be performed starting at time 90 min on a 18 cm-high thoraco-abdominal segment to include the left cardiac ventricle and most of the liver on a Philips Gemini TOF PET/CT
WAT spillover NEFA appearance rates
Time frame: 2 years
WAT spillover NEFA will be determined from oral administration of [U-13C]-palmitate. Blood samples to measure plasma [U-13C]-palmitate and chylomicron-TG [U-13C]-palmitate enrichment by GC/MS-MS
oxidative metabolism of NEFA
Time frame: 2 years
will be assessed by using 13C-palmitate
cardiac and hepatic DFA uptake
Time frame: 2 years
will be assessed using PET/CT method with oral administration of 18FTHA
whole-body organ-specific DFA partitioning
Time frame: 2 years
will be determined by whole-body CT (16 mA) followed by PET acquisition of 18FTHA
6 secondary outcomes
Insulin sensitivity
Time frame: 2 years
Insulin secretion rate
Time frame: 2 years
β-cell function
Time frame: 2 years
WAT size
Time frame: 2 years
hormonal response
Time frame: 2 years
Lipoprotein lipase 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 27 Jan 2025.
- Derived from this study: PubMed 40157702Montastier E, Ye RZ, Noll C, Amrani M, Frisch F, Fortin M, Bouffard L, Phoenix S, Sarrhini O, Cunnane SC, Guerin B, Turcotte EE, Carpentier AC. Nicotinic acid increases adipose tissue dietary fatty acid trapping and reduces postprandial hepatic and cardiac fatty acid uptake in prediabetes. Eur J Pharmacol. 2025 Jul 5;998:177563. doi: 10.1016/j.ejphar.2025.177563. Epub 2025 Mar 27.
- Derived from this study: PubMed 35748318Ye RZ, Montastier E, Noll C, Frisch F, Fortin M, Bouffard L, Phoenix S, Guerin B, Turcotte EE, Carpentier AC. Total Postprandial Hepatic Nonesterified and Dietary Fatty Acid Uptake Is Increased and Insufficiently Curbed by Adipose Tissue Fatty Acid Trapping in Prediabetes With Overweight. Diabetes. 2022 Sep 1;71(9):1891-1901. doi: 10.2337/db21-1097.
- Derived from this study: PubMed 33870714Montastier E, Ye RZ, Noll C, Bouffard L, Fortin M, Frisch F, Phoenix S, Guerin B, Turcotte EE, Lewis GF, Carpentier AC. Increased postprandial nonesterified fatty acid efflux from adipose tissue in prediabetes is offset by enhanced dietary fatty acid adipose trapping. Am J Physiol Endocrinol Metab. 2021 Jun 1;320(6):E1093-E1106. doi: 10.1152/ajpendo.00619.2020. Epub 2021 Apr 19.
- Total Postprandial Hepatic Nonesterified and Dietary Fatty Acid Uptake Is Increased and Insufficiently Curbed by Adipose Tissue Fatty Acid Trapping in Prediabetes With OverweightLink provided by the sponsor.
- Increased postprandial nonesterified fatty acid efflux from adipose tissue in prediabetes is offset by enhanced dietary fatty acid adipose trappingLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotinic acid, [7,7,8,8-2H]-palmitate and [U-13C]-palmitate in people with Impaired Glucose Tolerance, 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 2 inclusion and 8 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 27 Jan 2025. 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?
Plasma NEFA appearance rate (time frame: 2 years). The study lists 6 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 NCT02808182, which also lists 3 linked publications.
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 27 Jan 2025.