Type 2 DiabetesNCT01471509
Protein, Amino Acids & Insulin & Glucagon Secretion in Humans
A study testing water, glucose with or without amino acid in people with Type 2 Diabetes and Metabolic Syndrome, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of various foods and/or food substances such as fats or proteins on the blood glucose and insulin concentrations in people with and without type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Metabolic Syndrome
- What is being tested?
- water, glucose with or without amino acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1982to 6 Nov 2017
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with or without type 2 diabetes
- C-Peptide > 1.5 ng/ml
- Able to come to the Minneapolis VA Medical Center on several occasions over 2-4 weeks
Who cannot join
- Body mass index > 40
- hematologic abnormalities
- liver disease
- kidney disease
- congestive heart failure
- life threatening malignancies
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis VA Health Care System
Minneapolis, Minnesota, 55417
About this study
Official title: The Effect of Ingestion of Foods on the Plasma Glucose and Insulin Response in Subjects With Type 2 Diabetes: Protein, Amino Acids & Insulin & Glucagon Secretion in Humans
The purpose of this study is to determine the effect of various foods and/or food substances such as fats or proteins on the blood glucose and insulin concentrations in people with and without type 2 diabetes.
Read the detailed description
Various foods or food substances are given as a test meal. The metabolic response is determined at various times after the administration of the meal (e.g. blood glucose, and other hormones and metabolites).
- Conditions
- Type 2 Diabetes, Metabolic Syndrome
- Being tested
- water, glucose with or without amino acid
- Keywords
- Glycemic Index, LoBAG Diet, Insulin, Glucagon
- Medical subject headings
- Diabetes Mellitus, Type 2, Metabolic Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water, glucose with or without amino acidOther
Also called foods or food constituents
240 ml water, 50 g glucose ± 1 mmol amino acid/kg lean body mass
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | 240 ml water Receives: Other: water, glucose with or without amino acid |
| glucose | Active comparator | 50 g glucose Receives: Other: water, glucose with or without amino acid |
| Amino acid | Active comparator | 1 mmol amino acid/kg lean body mass Receives: Other: water, glucose with or without amino acid |
| amino acid plus glucose | Active comparator | 50 g glucose plus 1 mmol amino acid/kg lean body mass Receives: Other: water, glucose with or without amino acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood glucose concentration
Test substances will be given at 0800 hr and blood drawn at several time points up to 5 hours after the meal.
Measured: several time points after ingestion of test substance
Secondary outcomes (1)
Change in serum insulin concentration
Test substances will be given at 0800 hr and blood drawn at several time points up to 5 hours after the meal.
Measured: Several time points after ingestion of test substance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2011 (estimated)
- Study startAug 1982
- Primary completion6 Nov 2017
- Study completion6 Nov 2017 (estimated)
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 (43)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minneapolis Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Frank Q. Nuttall, MD, PhD, Minneapolis Veterans Affairs Medical Center
- Investigators
- Frank Q Nuttall, M.D., Ph.D., Principal investigator, Minneapolis Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471509
- Sponsor's protocol ID
- 676
- Status last verified
- Nov 2017
- First submitted
- 10 Nov 2011
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Iverson JF, Gannon MC, Nuttall FQ. Ingestion of leucine + phenylalanine with glucose produces an additive effect on serum insulin but less than additive effect on plasma glucose. J Amino Acids. 2013;2013:964637. doi: 10.1155/2013/964637. Epub 2013 Jul 29.
PubMed 23984046Iverson JF, Gannon MC, Nuttall FQ. Interaction of ingested leucine with glycine on insulin and glucose concentrations. J Amino Acids. 2014;2014:521941. doi: 10.1155/2014/521941. Epub 2014 Jul 10.
PubMed 25120925Nuttall FQ, Mooradian AD, Gannon MC, Billington C, Krezowski P. Effect of protein ingestion on the glucose and insulin response to a standardized oral glucose load. Diabetes Care. 1984 Sep-Oct;7(5):465-70. doi: 10.2337/diacare.7.5.465.
PubMed 6389060Nuttall FQ, Gannon MC, Wald JL, Ahmed M. Plasma glucose and insulin profiles in normal subjects ingesting diets of varying carbohydrate, fat, and protein content. J Am Coll Nutr. 1985;4(4):437-50. doi: 10.1080/07315724.1985.10720086.
PubMed 3900180Krezowski PA, Nuttall FQ, Gannon MC, Bartosh NH. The effect of protein ingestion on the metabolic response to oral glucose in normal individuals. Am J Clin Nutr. 1986 Dec;44(6):847-56. doi: 10.1093/ajcn/44.6.847.
PubMed 3538843Gannon MC, Nuttall FQ, Krezowski PA, Billington CJ, Parker S. The serum insulin and plasma glucose responses to milk and fruit products in type 2 (non-insulin-dependent) diabetic patients. Diabetologia. 1986 Nov;29(11):784-91. doi: 10.1007/BF00873217.
PubMed 3545955Krezowski PA, Nuttall FQ, Gannon MC, Billington CJ, Parker S. Insulin and glucose responses to various starch-containing foods in type II diabetic subjects. Diabetes Care. 1987 Mar-Apr;10(2):205-12. doi: 10.2337/diacare.10.2.205.
PubMed 3556106Gannon MC, Nuttall FQ. Factors affecting interpretation of postprandial glucose and insulin areas. Diabetes Care. 1987 Nov-Dec;10(6):759-63. doi: 10.2337/diacare.10.6.759.
PubMed 3322731Nuttall FQ, Gannon MC. Quantitative importance of dietary constituents other than glucose as insulin secretagogues in type II diabetes. Diabetes Care. 1988 Jan;11(1):72-6. doi: 10.2337/diacare.11.1.72.
PubMed 3276480Gannon MC, Nuttall FQ, Neil BJ, Westphal SA. The insulin and glucose responses to meals of glucose plus various proteins in type II diabetic subjects. Metabolism. 1988 Nov;37(11):1081-8. doi: 10.1016/0026-0495(88)90072-8.
PubMed 3054432Gannon MC, Nuttall FQ, Westphal SA, Neil BJ, Seaquist ER. Effects of dose of ingested glucose on plasma metabolite and hormone responses in type II diabetic subjects. Diabetes Care. 1989 Sep;12(8):544-52. doi: 10.2337/diacare.12.8.544.
PubMed 2673694Nuttall FQ, Gannon MC. Metabolic response to egg white and cottage cheese protein in normal subjects. Metabolism. 1990 Jul;39(7):749-55. doi: 10.1016/0026-0495(90)90112-p.
PubMed 2195298Westphal SA, Gannon MC, Nuttall FQ. Metabolic response to glucose ingested with various amounts of protein. Am J Clin Nutr. 1990 Aug;52(2):267-72. doi: 10.1093/ajcn/52.2.267.
PubMed 2197851Gannon MC, Nuttall FQ. Quantitation of the glucose area response to a meal. Diabetes Care. 1990 Oct;13(10):1095-6. doi: 10.2337/diacare.13.10.1095a. No abstract available.
PubMed 2209312Nuttall FQ, Gannon MC. Plasma glucose and insulin response to macronutrients in nondiabetic and NIDDM subjects. Diabetes Care. 1991 Sep;14(9):824-38. doi: 10.2337/diacare.14.9.824.
PubMed 1959475
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ingestion of Foods on the Plasma Glucose and Insulin Response in Subjects With Type 2 Diabetes: Protein, Amino Acids & Insulin & Glucagon Secretion in Humans
- ClinicalTrials.gov ID
- NCT01471509
- Acronym / sponsor ID
- 676
- Conditions
- Type 2 Diabetes, Metabolic Syndrome
- Keywords
- Glycemic Index, LoBAG Diet, Insulin, Glucagon
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Lack of funding
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Minneapolis Veterans Affairs Medical CenterUS federal agency
- Study start
- Aug 1982
- Primary completion
- 6 Nov 2017 (actual)
- Study completion
- 6 Nov 2017 (estimated)
- First posted
- 15 Nov 2011 (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.
The purpose of this study is to determine the effect of various foods and/or food substances such as fats or proteins on the blood glucose and insulin concentrations in people with and without type 2 diabetes.
Detailed description
Various foods or food substances are given as a test meal. The metabolic response is determined at various times after the administration of the meal (e.g. blood glucose, and other hormones and metabolites).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: water, glucose with or without amino acid240 ml water |
| glucose | Active comparator | Other: water, glucose with or without amino acid50 g glucose |
| Amino acid | Active comparator | Other: water, glucose with or without amino acid1 mmol amino acid/kg lean body mass |
| amino acid plus glucose | Active comparator | Other: water, glucose with or without amino acid50 g glucose plus 1 mmol amino acid/kg lean body mass |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with or without type 2 diabetes
- C-Peptide > 1.5 ng/ml
- Able to come to the Minneapolis VA Medical Center on several occasions over 2-4 weeks
Key exclusion criteria (6 listed)
- Body mass index > 40
- hematologic abnormalities
- liver disease
- kidney disease
- congestive heart failure
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 |
|---|---|---|
| water, glucose with or without amino acidAlso: foods or food constituents240 ml water, 50 g glucose ± 1 mmol amino acid/kg lean body mass | Other | Amino acid, Control, amino acid plus glucose, glucose |
Primary outcome
Change in blood glucose concentration
Time frame: several time points after ingestion of test substance
Test substances will be given at 0800 hr and blood drawn at several time points up to 5 hours after the meal.
1 secondary outcome
Change in serum insulin concentration
Time frame: Several time points after ingestion of test substance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
- Background: PubMed 23984046Iverson JF, Gannon MC, Nuttall FQ. Ingestion of leucine + phenylalanine with glucose produces an additive effect on serum insulin but less than additive effect on plasma glucose. J Amino Acids. 2013;2013:964637. doi: 10.1155/2013/964637. Epub 2013 Jul 29.
- Background: PubMed 25120925Iverson JF, Gannon MC, Nuttall FQ. Interaction of ingested leucine with glycine on insulin and glucose concentrations. J Amino Acids. 2014;2014:521941. doi: 10.1155/2014/521941. Epub 2014 Jul 10.
- Results publication: PubMed 6389060Nuttall FQ, Mooradian AD, Gannon MC, Billington C, Krezowski P. Effect of protein ingestion on the glucose and insulin response to a standardized oral glucose load. Diabetes Care. 1984 Sep-Oct;7(5):465-70. doi: 10.2337/diacare.7.5.465.
- Results publication: PubMed 3900180Nuttall FQ, Gannon MC, Wald JL, Ahmed M. Plasma glucose and insulin profiles in normal subjects ingesting diets of varying carbohydrate, fat, and protein content. J Am Coll Nutr. 1985;4(4):437-50. doi: 10.1080/07315724.1985.10720086.
- Results publication: PubMed 3538843Krezowski PA, Nuttall FQ, Gannon MC, Bartosh NH. The effect of protein ingestion on the metabolic response to oral glucose in normal individuals. Am J Clin Nutr. 1986 Dec;44(6):847-56. doi: 10.1093/ajcn/44.6.847.
- Results publication: PubMed 3545955Gannon MC, Nuttall FQ, Krezowski PA, Billington CJ, Parker S. The serum insulin and plasma glucose responses to milk and fruit products in type 2 (non-insulin-dependent) diabetic patients. Diabetologia. 1986 Nov;29(11):784-91. doi: 10.1007/BF00873217.
- Results publication: PubMed 3556106Krezowski PA, Nuttall FQ, Gannon MC, Billington CJ, Parker S. Insulin and glucose responses to various starch-containing foods in type II diabetic subjects. Diabetes Care. 1987 Mar-Apr;10(2):205-12. doi: 10.2337/diacare.10.2.205.
- Results publication: PubMed 3322731Gannon MC, Nuttall FQ. Factors affecting interpretation of postprandial glucose and insulin areas. Diabetes Care. 1987 Nov-Dec;10(6):759-63. doi: 10.2337/diacare.10.6.759.
- Results publication: PubMed 3276480Nuttall FQ, Gannon MC. Quantitative importance of dietary constituents other than glucose as insulin secretagogues in type II diabetes. Diabetes Care. 1988 Jan;11(1):72-6. doi: 10.2337/diacare.11.1.72.
- Results publication: PubMed 3054432Gannon MC, Nuttall FQ, Neil BJ, Westphal SA. The insulin and glucose responses to meals of glucose plus various proteins in type II diabetic subjects. Metabolism. 1988 Nov;37(11):1081-8. doi: 10.1016/0026-0495(88)90072-8.
- Results publication: PubMed 2673694Gannon MC, Nuttall FQ, Westphal SA, Neil BJ, Seaquist ER. Effects of dose of ingested glucose on plasma metabolite and hormone responses in type II diabetic subjects. Diabetes Care. 1989 Sep;12(8):544-52. doi: 10.2337/diacare.12.8.544.
- Results publication: PubMed 2195298Nuttall FQ, Gannon MC. Metabolic response to egg white and cottage cheese protein in normal subjects. Metabolism. 1990 Jul;39(7):749-55. doi: 10.1016/0026-0495(90)90112-p.
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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.
Frank Q Nuttall, M.D., Ph.D. principal investigator
Minneapolis Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing water, glucose with or without amino acid in people with Type 2 Diabetes and Metabolic Syndrome, run by Minneapolis Veterans Affairs Medical Center 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: paused, as of the sponsor's last update on 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
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?
Change in blood glucose concentration (time frame: several time points after ingestion of test substance). 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 NCT01471509, which also lists 43 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 8 Nov 2017.