Weight GainNCT00340132
Cross-Sectional and Longitudinal Studies of "Pre-Diabetes" in the Pima Indians
An observational study of Weight Gain and Overweight, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Insulin resistance and a defect in early insulin secretion are risk factors for the development of type 2 diabetes mellitus. A recent longitudinal analysis which tracked the development of diabetes demonstrated that both insulin action and early insulin secretion deteriorate as individuals progress from normal to… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Weight Gain, Overweight, Insulin Resistance
- How many people
- 1,759 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 1983to not given
- Phase
- Observational
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Community sample from eligible participants from greater Phoenix metropolitan area@@@@@@
Who may be able to join
- Subjects from all racial and ethnic backgrounds will be invited to participate if they are:
- Ages: 18-55 years old (up to 2200 participants)
- Gender: male or female
Who cannot join
- Subjects will be excluded who are:
- Taking medication for a chronic illness.
- Have any acute or chronic diseases or conditions not specifically mentioned that in the opinion of the provider may interfere with the study or decrease safety for participation will be considered exclusionary.
- Women who currently pregnant or breastfeeding.
- Positive for drug and/or nicotine use.
- All medications and alcohol consumption are to be stopped for two weeks prior to admission. A urine drug-screening test for drugs such as narcotics, marijuana, and barbiturates will be performed on everyone to exclude from the study people whose urine show active or recent drug use. A positive drug test could confound the results of the study in an unpredictable manner. The results of this test will become a part of the patient s medical records and may be released if requested (please see page 6 of the consent for details regarding medical records release).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross-Sectional and Longitudinal Studies of 'Pre-Diabetes'
Insulin resistance and a defect in early insulin secretion are risk factors for the development of type 2 diabetes mellitus. A recent longitudinal analysis which tracked the development of diabetes demonstrated that both insulin action and early insulin secretion deteriorate as individuals progress from normal to impaired glucose tolerance and then to diabetes. These results suggest that both inherent (apparent in normal glucose tolerant subjects who progress to diabetes and likely to have a genetic basis) and acquired (evident as individuals progress from NGT to IGT to diabetes and possibly environmental in origin) defects in insulin action and secretion contribute to the pathogenesis of type 2 diabetes. To identify the genetic and environmental determinants of diabetes we are continuing to determine: (1) if there are genes that segregate with metabolic risk factors for diabetes which might therefore be genetic markers for type 2 diabetes and (2) the mechanisms mediating genetic and environmental determinants of insulin resistance and impaired insulin secretion.
<TAB>
Read more
Volunteers for this study will be admitted to the clinical research ward where they will undergo several tests to determine body composition, oral and intravenous glucose tolerance and in vivo insulin action. In addition, in selected subjects, adipose and/or skeletal muscle tissue will be obtained by percutaneous biopsy for in vitro studies of gene expression and insulin action in these tissues. A transformed lymphocyte cell line will be established for each subject as a permanent source of DNA for genetic studies. Genetic markers for type 2 diabetes and insulin resistance will be sought by typing each individual at positional and functional candidate loci in the hopes of finding an association between these loci and obesity, insulin secretion, insulin resistance and/or type 2 diabetes.
...
Read the detailed description
Insulin resistance and a defect in early insulin secretion are risk factors for the development of type 2 diabetes mellitus. A recent longitudinal analysis which tracked the development of diabetes demonstrated that both insulin action and early insulin secretion deteriorate as individuals progress from normal to impaired glucose tolerance and then to diabetes. These results suggest that both inherent (apparent in normal glucose tolerant subjects who progress to diabetes and likely to have a genetic basis) and acquired (evident as individuals progress from NGT to IGT to diabetes and possibly environmental in origin) defects in insulin action and secretion contribute to the pathogenesis of type 2 diabetes. To identify the genetic and environmental determinants of diabetes we are continuing to determine: (1) if there are genes that segregate with metabolic risk factors for diabetes which might therefore be genetic markers for type 2 diabetes and (2) the mechanisms mediating genetic and environmental determinants of insulin resistance and impaired insulin secretion.
<TAB>
Volunteers for this study will be admitted to the clinical research ward where they will undergo several tests to determine body composition, oral and intravenous glucose tolerance and in vivo insulin action. In addition, in selected subjects, adipose and/or skeletal muscle tissue will be obtained by percutaneous biopsy for in vitro studies of gene expression and insulin action in these tissues. A transformed lymphocyte cell line will be established for each subject as a permanent source of DNA for genetic studies. Genetic markers for type 2 diabetes and insulin resistance will be sought by typing each individual at positional and functional candidate loci in the hopes of finding an association between these loci and obesity, insulin secretion, insulin resistance and/or type 2 diabetes.
- Conditions
- Weight Gain, Overweight, Insulin Resistance, Obesity, Diabetes Mellitus, Type 2
- Keywords
- Insulin Sensitivity, Insulin Secretion, Glucose Tolerance, Adipose Tissue, Preadipocytes, Natural History
- Medical subject headings
- Weight Gain, Overweight, Insulin Resistance, Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult volunteers | Volunteers aged 18-55 who are healthy as determined by medical history, physical examination, and laboratory tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose tolerance via oral glucose tolerance test (OGTT)
Measured via OGTT after ingestion of 75 grams of glucose over 2 minutes
Measured: Baseline, and after 180 minutes on day 4
Glucose tolerance via intravenous glucose tolerance test (IVGTT)
Measured via IVGTT after administration of a glucose bolus (25 g as a 50% solution injected over 3 minutes)
Measured: Baseline and after 10 minutes on day 5
Basal endogenous glucose production
Assessed using deuterium (D-6,6 2H) glucose as a tracer, infused as a 10 mL bolus followed by 0.150 mL/min for a total of 350 minutes
Measured: Baseline, and after 100 minutes on day 10
24-hour metabolic rate
Assessed from the rates of caloric expenditure and substrate utilization while in the human respiratory chamber for 24 hours
Measured: Baseline and after 23.5 hours on day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start1 Jan 1983
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Weight GainStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,759 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Susanne M Votruba, Ph.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00340132
- Sponsor's protocol ID
- 9999820136
- Other IDs
- OH82-DK-0136
- Status last verified
- 30 Sep 2026
- First submitted
- 19 Jun 2006
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aydin BN, Stinson EJ, Looker HC, Walter P, Cabeza de Baca T, Krakoff J, Chang DC. Cholecystectomy Is Linked With Lower Respiratory Exchange Ratio and Higher Lipid Oxidation and Sleep Energy Expenditure. Obesity (Silver Spring). 2026 Apr;34(4):793-800. doi: 10.1002/oby.70145. Epub 2026 Feb 12.
PubMed 41677021Aydin BN, Stinson EJ, Hanson RL, Looker HC, Cabeza De Baca T, Krakoff J, Chang DC. Hepatic Insulin Resistance Increases Risk of Gallstone Disease in Indigenous Americans in the Southwestern United States. Clin Transl Gastroenterol. 2024 Nov 1;15(11):e00763. doi: 10.14309/ctg.0000000000000763.
PubMed 39166750Mitchell CM, Stinson EJ, Chang DC, Krakoff J. A mixed meal tolerance test predicts onset of type 2 diabetes in Southwestern Indigenous adults. Nutr Diabetes. 2024 Jul 10;14(1):50. doi: 10.1038/s41387-024-00269-3.
PubMed 38987291Willig MR, Stinson EJ, Looker HC, Piaggi P, Mitchell CM, Hanson RL, Nelson RG, Krakoff J, Chang DC. Insulin resistance before type 2 diabetes onset is associated with increased risk of albuminuria after diabetes onset: A prospective cohort study. Diabetes Obes Metab. 2024 May;26(5):1888-1896. doi: 10.1111/dom.15505. Epub 2024 Feb 28.
PubMed 38419421Aydin BN, Stinson EJ, Cabeza De Baca T, Ando T, Travis KT, Piaggi P, Krakoff J, Chang DC. Investigation of seasonality of human spontaneous physical activity and energy expenditure in respiratory chamber in Phoenix, Arizona. Eur J Clin Nutr. 2024 Jan;78(1):27-33. doi: 10.1038/s41430-023-01347-y. Epub 2023 Oct 13.
PubMed 37833567Stinson EJ, Mitchell CM, Looker HC, Krakoff J, Chang DC. Higher glucose and insulin responses to a mixed meal are associated with increased risk of diabetic retinopathy in Indigenous Americans. J Endocrinol Invest. 2024 Mar;47(3):699-707. doi: 10.1007/s40618-023-02187-0. Epub 2023 Sep 9.
PubMed 37684485Basolo A, Ando T, Chang DC, Hollstein T, Krakoff J, Piaggi P, Votruba S. Reduced Albumin Concentration Predicts Weight Gain and Higher Ad Libitum Energy Intake in Humans. Front Endocrinol (Lausanne). 2021 Mar 11;12:642568. doi: 10.3389/fendo.2021.642568. eCollection 2021.
PubMed 33776937Shah MH, Piaggi P, Looker HC, Paddock E, Krakoff J, Chang DC. Lower insulin clearance is associated with increased risk of type 2 diabetes in Native Americans. Diabetologia. 2021 Apr;64(4):914-922. doi: 10.1007/s00125-020-05348-5. Epub 2021 Jan 6.
PubMed 33404681Piaggi P, Koroglu C, Nair AK, Sutherland J, Muller YL, Kumar P, Hsueh WC, Kobes S, Shuldiner AR, Kim HI, Gosalia N, Van Hout CV, Jones M, Knowler WC, Krakoff J, Hanson RL, Bogardus C, Baier LJ. Exome Sequencing Identifies A Nonsense Variant in DAO Associated With Reduced Energy Expenditure in American Indians. J Clin Endocrinol Metab. 2020 Nov 1;105(11):e3989-4000. doi: 10.1210/clinem/dgaa548.
PubMed 32818236Heinitz S, Gebhardt C, Piaggi P, Kruger J, Heyne H, Weiner J, Heiker JT, Stumvoll M, Bluher M, Baier L, Rudich A, Kovacs P, Tonjes A. Atg7 Knockdown Reduces Chemerin Secretion in Murine Adipocytes. J Clin Endocrinol Metab. 2019 Nov 1;104(11):5715-5728. doi: 10.1210/jc.2018-01980.
PubMed 31225870Heinitz S, Basolo A, Piomelli D, Krakoff J, Piaggi P. Endocannabinoid Anandamide Mediates the Effect of Skeletal Muscle Sphingomyelins on Human Energy Expenditure. J Clin Endocrinol Metab. 2018 Oct 1;103(10):3757-3766. doi: 10.1210/jc.2018-00780.
PubMed 30113648Heinitz S, Piaggi P, Yang S, Bonfiglio S, Steel J, Krakoff J, Votruba SB. Response of skeletal muscle UCP2-expression during metabolic adaptation to caloric restriction. Int J Obes (Lond). 2018 Jun;42(5):974-984. doi: 10.1038/s41366-018-0085-2. Epub 2018 May 17.
PubMed 29777235Heinitz S, Basolo A, Piaggi P, Piomelli D, Jumpertz von Schwartzenberg R, Krakoff J. Peripheral Endocannabinoids Associated With Energy Expenditure in Native Americans of Southwestern Heritage. J Clin Endocrinol Metab. 2018 Mar 1;103(3):1077-1087. doi: 10.1210/jc.2017-02257.
PubMed 29300902Piaggi P, Masindova I, Muller YL, Mercader J, Wiessner GB, Chen P; SIGMA Type 2 Diabetes Consortium; Kobes S, Hsueh WC, Mongalo M, Knowler WC, Krakoff J, Hanson RL, Bogardus C, Baier LJ. A Genome-Wide Association Study Using a Custom Genotyping Array Identifies Variants in GPR158 Associated With Reduced Energy Expenditure in American Indians. Diabetes. 2017 Aug;66(8):2284-2295. doi: 10.2337/db16-1565. Epub 2017 May 5.
PubMed 28476931Hohenadel MG, Baier LJ, Piaggi P, Muller YL, Hanson RL, Krakoff J, Thearle MS. The impact of genetic variants on BMI increase during childhood versus adulthood. Int J Obes (Lond). 2016 Aug;40(8):1301-9. doi: 10.1038/ijo.2016.53. Epub 2016 Apr 14.
PubMed 27076275
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Sectional and Longitudinal Studies of 'Pre-Diabetes'
- ClinicalTrials.gov ID
- NCT00340132
- Acronym / sponsor ID
- 9999820136
- Conditions
- Weight Gain, Overweight, Insulin Resistance, Obesity, Diabetes Mellitus, Type 2
- Keywords
- Insulin Sensitivity, Insulin Secretion, Glucose Tolerance, Adipose Tissue, Preadipocytes, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,759 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 1 Jan 1983 (actual)
- First posted
- 21 Jun 2006 (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.
Insulin resistance and a defect in early insulin secretion are risk factors for the development of type 2 diabetes mellitus. A recent longitudinal analysis which tracked the development of diabetes demonstrated that both insulin action and early insulin secretion deteriorate as individuals progress from normal to impaired glucose tolerance and then to diabetes. These results suggest that both inherent (apparent in normal glucose tolerant subjects who progress to diabetes and likely to have a genetic basis) and acquired (evident as individuals progress from NGT to IGT to diabetes and possibly environmental in origin) defects in insulin action and secretion contribute to the pathogenesis of type 2 diabetes. To identify the genetic and environmental determinants of diabetes we are continuing to determine: (1) if there are genes that segregate with metabolic risk factors for diabetes which might therefore be genetic markers for type 2 diabetes and (2) the mechanisms mediating genetic and environmental determinants of insulin resistance and impaired insulin secretion.
<TAB>
Volunteers for this study will be admitted to the clinical research ward where they will undergo several tests to determine body composition, oral and intravenous glucose tolerance and in vivo insulin action. In addition, in selected subjects, adipose and/or skeletal muscle tissue will be obtained by percutaneous biopsy for in vitro studies of gene expression and insulin action in these tissues. A transformed lymphocyte cell line will be established for each subject as a permanent source of DNA for genetic studies. Genetic markers for type 2 diabetes and insulin resistance will be sought by typing each individual at positional and functional candidate loci in the hopes of finding an association between these loci and obesity, insulin secretion, insulin resistance and/or type 2 diabetes.
...
Detailed description
Insulin resistance and a defect in early insulin secretion are risk factors for the development of type 2 diabetes mellitus. A recent longitudinal analysis which tracked the development of diabetes demonstrated that both insulin action and early insulin secretion deteriorate as individuals progress from normal to impaired glucose tolerance and then to diabetes. These results suggest that both inherent (apparent in normal glucose tolerant subjects who progress to diabetes and likely to have a genetic basis) and acquired (evident as individuals progress from NGT to IGT to diabetes and possibly environmental in origin) defects in insulin action and secretion contribute to the pathogenesis of type 2 diabetes. To identify the genetic and environmental determinants of diabetes we are continuing to determine: (1) if there are genes that segregate with metabolic risk factors for diabetes which might therefore be genetic markers for type 2 diabetes and (2) the mechanisms mediating genetic and environmental determinants of insulin resistance and impaired insulin secretion.
<TAB>
Volunteers for this study will be admitted to the clinical research ward where they will undergo several tests to determine body composition, oral and intravenous glucose tolerance and in vivo insulin action. In addition, in selected subjects, adipose and/or skeletal muscle tissue will be obtained by percutaneous biopsy for in vitro studies of gene expression and insulin action in these tissues. A transformed lymphocyte cell line will be established for each subject as a permanent source of DNA for genetic studies. Genetic markers for type 2 diabetes and insulin resistance will be sought by typing each individual at positional and functional candidate loci in the hopes of finding an association between these loci and obesity, insulin secretion, insulin resistance and/or type 2 diabetes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult volunteers | – | –Volunteers aged 18-55 who are healthy as determined by medical history, physical examination, and laboratory tests |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Community sample from eligible participants from greater Phoenix metropolitan area@@@@@@
Key inclusion criteria (3 listed)
- Subjects from all racial and ethnic backgrounds will be invited to participate if they are:
- Ages: 18-55 years old (up to 2200 participants)
- Gender: male or female
Key exclusion criteria (6 listed)
- Taking medication for a chronic illness.
- Have any acute or chronic diseases or conditions not specifically mentioned that in the opinion of the provider may interfere with the study or decrease safety for participation will be considered exclusionary.
- Women who currently pregnant or breastfeeding.
- Positive for drug and/or nicotine use.
- All medications and alcohol consumption are to be stopped for two weeks prior to admission. A urine drug-screening test for drugs such as narcotics, marijuana, and barbiturates will be performed on everyone to exclude from the study people whose urine show active or recent drug use. A positive drug test could confound the results of the study in an unpredictable manner. The results of this test will become a part of the patient s medical records and may be released if requested (please see page 6 of the consent for details regarding medical records release).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Glucose tolerance via oral glucose tolerance test (OGTT)
Time frame: Baseline, and after 180 minutes on day 4
Measured via OGTT after ingestion of 75 grams of glucose over 2 minutes
Glucose tolerance via intravenous glucose tolerance test (IVGTT)
Time frame: Baseline and after 10 minutes on day 5
Measured via IVGTT after administration of a glucose bolus (25 g as a 50% solution injected over 3 minutes)
Basal endogenous glucose production
Time frame: Baseline, and after 100 minutes on day 10
Assessed using deuterium (D-6,6 2H) glucose as a tracer, infused as a 10 mL bolus followed by 0.150 mL/min for a total of 350 minutes
24-hour metabolic rate
Time frame: Baseline and after 23.5 hours on day 7
Assessed from the rates of caloric expenditure and substrate utilization while in the human respiratory chamber for 24 hours
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 5 Nov 2026.
- Derived from this study: PubMed 41677021Aydin BN, Stinson EJ, Looker HC, Walter P, Cabeza de Baca T, Krakoff J, Chang DC. Cholecystectomy Is Linked With Lower Respiratory Exchange Ratio and Higher Lipid Oxidation and Sleep Energy Expenditure. Obesity (Silver Spring). 2026 Apr;34(4):793-800. doi: 10.1002/oby.70145. Epub 2026 Feb 12.
- Derived from this study: PubMed 39166750Aydin BN, Stinson EJ, Hanson RL, Looker HC, Cabeza De Baca T, Krakoff J, Chang DC. Hepatic Insulin Resistance Increases Risk of Gallstone Disease in Indigenous Americans in the Southwestern United States. Clin Transl Gastroenterol. 2024 Nov 1;15(11):e00763. doi: 10.14309/ctg.0000000000000763.
- Derived from this study: PubMed 38987291Mitchell CM, Stinson EJ, Chang DC, Krakoff J. A mixed meal tolerance test predicts onset of type 2 diabetes in Southwestern Indigenous adults. Nutr Diabetes. 2024 Jul 10;14(1):50. doi: 10.1038/s41387-024-00269-3.
- Derived from this study: PubMed 38419421Willig MR, Stinson EJ, Looker HC, Piaggi P, Mitchell CM, Hanson RL, Nelson RG, Krakoff J, Chang DC. Insulin resistance before type 2 diabetes onset is associated with increased risk of albuminuria after diabetes onset: A prospective cohort study. Diabetes Obes Metab. 2024 May;26(5):1888-1896. doi: 10.1111/dom.15505. Epub 2024 Feb 28.
- Derived from this study: PubMed 37833567Aydin BN, Stinson EJ, Cabeza De Baca T, Ando T, Travis KT, Piaggi P, Krakoff J, Chang DC. Investigation of seasonality of human spontaneous physical activity and energy expenditure in respiratory chamber in Phoenix, Arizona. Eur J Clin Nutr. 2024 Jan;78(1):27-33. doi: 10.1038/s41430-023-01347-y. Epub 2023 Oct 13.
- Derived from this study: PubMed 37684485Stinson EJ, Mitchell CM, Looker HC, Krakoff J, Chang DC. Higher glucose and insulin responses to a mixed meal are associated with increased risk of diabetic retinopathy in Indigenous Americans. J Endocrinol Invest. 2024 Mar;47(3):699-707. doi: 10.1007/s40618-023-02187-0. Epub 2023 Sep 9.
- Derived from this study: PubMed 33776937Basolo A, Ando T, Chang DC, Hollstein T, Krakoff J, Piaggi P, Votruba S. Reduced Albumin Concentration Predicts Weight Gain and Higher Ad Libitum Energy Intake in Humans. Front Endocrinol (Lausanne). 2021 Mar 11;12:642568. doi: 10.3389/fendo.2021.642568. eCollection 2021.
- Derived from this study: PubMed 33404681Shah MH, Piaggi P, Looker HC, Paddock E, Krakoff J, Chang DC. Lower insulin clearance is associated with increased risk of type 2 diabetes in Native Americans. Diabetologia. 2021 Apr;64(4):914-922. doi: 10.1007/s00125-020-05348-5. Epub 2021 Jan 6.
- Derived from this study: PubMed 32818236Piaggi P, Koroglu C, Nair AK, Sutherland J, Muller YL, Kumar P, Hsueh WC, Kobes S, Shuldiner AR, Kim HI, Gosalia N, Van Hout CV, Jones M, Knowler WC, Krakoff J, Hanson RL, Bogardus C, Baier LJ. Exome Sequencing Identifies A Nonsense Variant in DAO Associated With Reduced Energy Expenditure in American Indians. J Clin Endocrinol Metab. 2020 Nov 1;105(11):e3989-4000. doi: 10.1210/clinem/dgaa548.
- Derived from this study: PubMed 31225870Heinitz S, Gebhardt C, Piaggi P, Kruger J, Heyne H, Weiner J, Heiker JT, Stumvoll M, Bluher M, Baier L, Rudich A, Kovacs P, Tonjes A. Atg7 Knockdown Reduces Chemerin Secretion in Murine Adipocytes. J Clin Endocrinol Metab. 2019 Nov 1;104(11):5715-5728. doi: 10.1210/jc.2018-01980.
- Derived from this study: PubMed 30113648Heinitz S, Basolo A, Piomelli D, Krakoff J, Piaggi P. Endocannabinoid Anandamide Mediates the Effect of Skeletal Muscle Sphingomyelins on Human Energy Expenditure. J Clin Endocrinol Metab. 2018 Oct 1;103(10):3757-3766. doi: 10.1210/jc.2018-00780.
- Derived from this study: PubMed 29777235Heinitz S, Piaggi P, Yang S, Bonfiglio S, Steel J, Krakoff J, Votruba SB. Response of skeletal muscle UCP2-expression during metabolic adaptation to caloric restriction. Int J Obes (Lond). 2018 Jun;42(5):974-984. doi: 10.1038/s41366-018-0085-2. Epub 2018 May 17.
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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.
Susanne M Votruba, Ph.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Gain and Overweight, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 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 5 Nov 2026. 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?
Glucose tolerance via oral glucose tolerance test (OGTT) (time frame: Baseline, and after 180 minutes on day 4). 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 NCT00340132, which also lists 17 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 5 Nov 2026.