Branched-chain Amino Acid MetabolismBCAAM-PDNCT01786941
Regulation of Branched-chain Amino Acid Metabolism in Pre-Diabetes
A study testing Pre-Diabetes Group - 6-mo Aerobic and Resistance combined exercise training and GBP Group - Non-diabetics intending to undergo Gastric Bypass surgery in people with Branched-chain Amino Acid Metabolism and Insulin Sensitivity, run by Duke University at 1 site in United States.
Trial summary
Elevated circulating levels of certain amino acids (the building blocks of protein) are strongly associated with insulin resistance. This study will investigate the metabolism of these amino acids in individuals with normal glucose metabolism compared to overweight or obese pre-diabetic individuals. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Branched-chain Amino Acid Metabolism, Insulin Sensitivity
- What is being tested?
- Pre-Diabetes Group - 6-mo Aerobic and Resistance combined exercise training and GBP Group - Non-diabetics intending to undergo Gastric Bypass surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Dec 2013
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age:
- Lean and Overweight Pre-diabetic (PD) groups: 40-65 years
- Obese Gastric Bypass (GBP) patients: 30-65 years
- Body Mass Index (BMI) within desired range for group:
- Lean group: 18.0 - 24.9
- Overweight PD group: 25.0 - 35.4
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- GBP group: 35.0 - 50.0
- Fasting Plasma Glucose level within desired range for group:
- Lean: < 99 mg/dL
- PD: > 105 - < 126 mg/dL
- GBP: > 99
- Oral Glucose Tolerance Test, 2-hour Plasma Glucose results within desired range:
- Lean: < 139 mg/dL
- PD: 140-199 mg/dL
- Low density (LDL) cholesterol: < 190 mg/dL
- Triglycerides: < 600 mg/dL
- Resting blood pressure: <160/90 mmHg
- Inactive: Exercise < two days/week (GBP and PD only);
- Peak oxygen use: > 14.0 - < 40.0 ml/kg/min (PD only)
- Medications: Stable use of all medications for > three months
- Body Weight < 495 lbs
Who cannot join
- Smoker: Tobacco use within the last 12 months
- Dieting or intending to diet (excluding intention for gastric bypass procedure in GBP group)- Not weight stable for > six months or weight loss exceeding five pounds in last six months
- Use of potential confounding medications, e.g. Niacin containing drugs
- History of diabetes, heart disease or taking medication for those conditions
- History of hypertension (high blood pressure) not controlled with medication
- Pregnant or intending to become pregnant
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- Unwillingness to participate in study visits, submit to skeletal muscle biopsies and all other study testing or continuously participate in the exercise training intervention program for six months if in overweight PD group
- Orthopedic limitations, musculoskeletal disease and/or injury
- Allergic to xylocaine
- Inability to give blood continuously through an intravenous catheter
- Unwillingness to exercise at least three times per week at the Duke Center for Living during staff supervised times (PD only)
- Exercise compliance less than 85% in any 6 week period (missing > 3 exercise sessions in a 6 week period)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Regulation of Branched-chain Amino Acid Metabolism in Pre-Diabetes: Responses to Exercise Training and Gastric Bypass Surgery
Elevated circulating levels of certain amino acids (the building blocks of protein) are strongly associated with insulin resistance. This study will investigate the metabolism of these amino acids in individuals with normal glucose metabolism compared to overweight or obese pre-diabetic individuals. The purpose of this study is to determine how elevated levels of the branched-chain amino acids may contribute to the development of insulin resistance and ultimately diabetes. An additional purpose is to determine whether exercise or gastric bypass (GBP) surgery intervention can correct aberrations in branched-chain amino acid metabolism as insulin sensitivity improves. This information will be used to further our understanding of the development of insulin resistance and type 2 diabetes in at-risk populations and potentially improve clinical treatment of such conditions.
- Being tested
- Pre-Diabetes Group - 6-mo Aerobic and Resistance combined exercise training, GBP Group - Non-diabetics intending to undergo Gastric Bypass surgery
- Keywords
- Branched-chain Amino Acids, Insulin Sensitivity, Exercise, Leucine
- Medical subject headings
- Insulin Resistance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-Diabetes Group - 6-mo Aerobic and Resistance combined exercise trainingOther
GBP Group - Non-diabetics intending to undergo Gastric Bypass surgeryOther
| Study group | Role | What they receive |
|---|---|---|
| Lean Group | No intervention | Healthy Controls - no intervention |
| Pre-Diabetes Group | Other | Pre-Diabetes Group will undergo a 6-mo Aerobic and Resistance combined exercise training intervention Receives: Other: Pre-Diabetes Group - 6-mo Aerobic and Resistance combined exercise training |
| Gastric Bypass Group | Other | Non-diabetic patients intending to undergo Gastric Bypass surgery Receives: Other: GBP Group - Non-diabetics intending to undergo Gastric Bypass surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Branched-chain Amino Acid Metabolism in Pre-Diabetes at Baseline and post-intervention
- Lean Healthy Controls - Baseline only
- Pre-Diabetic Group - Baseline and 6-months post the Aerobic and Resistance combined exercise training intervention
- Gastric Bypass Group - Baseline and 3-months post Gastric Bypass surgery
Measured: Baseline and pre- and post-intervention: 1) Lean Group-Baseline measures only; 2)Pre-Diabetic group - Baseline and 6-months post exercise intervention; 3) GBP group - Baseline and 3-months post Gastric Bypass Surgery
Secondary outcomes (1)
Changes in Insulin Sensitivity at Baseline and post-intervention
- Lean Healthy Controls - Baseline only
- Pre-Diabetic Group - Baseline and 6-months post the Aerobic and Resistance combined exercise training intervention
- Gastric Bypass Group - Baseline and 3-months post Gastric Bypass surgery
Measured: Baseline and pre- and post-intervention: 1) Lean Group-Baseline measures only; 2)Pre-Diabetic group - Baseline and 6-months post exercise intervention; 3) GBP group - Baseline and 3-months post Gastric Bypass Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startJun 2012
- Primary completionDec 2013
- Study completionDec 2013
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 Branched-chain Amino Acid MetabolismStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- William E. Kraus, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786941
- Sponsor's protocol ID
- Pro00034434
- Acronym
- BCAAM-PD
- Status last verified
- Oct 2015
- First submitted
- 6 Feb 2013
- Last updated
- 19 Oct 2015
- Results posted
- No
Publications
Glynn EL, Piner LW, Huffman KM, Slentz CA, Elliot-Penry L, AbouAssi H, White PJ, Bain JR, Muehlbauer MJ, Ilkayeva OR, Stevens RD, Porter Starr KN, Bales CW, Volpi E, Brosnan MJ, Trimmer JK, Rolph TP, Newgard CB, Kraus WE. Impact of combined resistance and aerobic exercise training on branched-chain amino acid turnover, glycine metabolism and insulin sensitivity in overweight humans. Diabetologia. 2015 Oct;58(10):2324-35. doi: 10.1007/s00125-015-3705-6. Epub 2015 Aug 9.
PubMed 26254576
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Branched-chain Amino Acid Metabolism in Pre-Diabetes: Responses to Exercise Training and Gastric Bypass Surgery
- ClinicalTrials.gov ID
- NCT01786941
- Acronym / sponsor ID
- BCAAM-PD / Pro00034434
- Keywords
- Branched-chain Amino Acids, Insulin Sensitivity, Exercise, Leucine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jun 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 8 Feb 2013 (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.
Elevated circulating levels of certain amino acids (the building blocks of protein) are strongly associated with insulin resistance. This study will investigate the metabolism of these amino acids in individuals with normal glucose metabolism compared to overweight or obese pre-diabetic individuals. The purpose of this study is to determine how elevated levels of the branched-chain amino acids may contribute to the development of insulin resistance and ultimately diabetes. An additional purpose is to determine whether exercise or gastric bypass (GBP) surgery intervention can correct aberrations in branched-chain amino acid metabolism as insulin sensitivity improves. This information will be used to further our understanding of the development of insulin resistance and type 2 diabetes in at-risk populations and potentially improve clinical treatment of such conditions.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lean Group | No intervention | –Healthy Controls - no intervention |
| Pre-Diabetes Group | Other | Other: Pre-Diabetes Group - 6-mo Aerobic and Resistance combined exercise trainingPre-Diabetes Group will undergo a 6-mo Aerobic and Resistance combined exercise training intervention |
| Gastric Bypass Group | Other | Other: GBP Group - Non-diabetics intending to undergo Gastric Bypass surgeryNon-diabetic patients intending to undergo Gastric Bypass surgery |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age:
- Body Mass Index (BMI) within desired range for group:
- Fasting Plasma Glucose level within desired range for group:
- Oral Glucose Tolerance Test, 2-hour Plasma Glucose results within desired range:
- Low density (LDL) cholesterol: < 190 mg/dL
Key exclusion criteria (12 listed)
- Smoker: Tobacco use within the last 12 months
- Dieting or intending to diet (excluding intention for gastric bypass procedure in GBP group)- Not weight stable for > six months or weight loss exceeding five pounds in last six months
- Use of potential confounding medications, e.g. Niacin containing drugs
- History of diabetes, heart disease or taking medication for those conditions
- History of hypertension (high blood pressure) not controlled with medication
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 |
|---|---|---|
| Pre-Diabetes Group - 6-mo Aerobic and Resistance combined exercise training | Other | Pre-Diabetes Group |
| GBP Group - Non-diabetics intending to undergo Gastric Bypass surgery | Other | Gastric Bypass Group |
Primary outcome
Changes in Branched-chain Amino Acid Metabolism in Pre-Diabetes at Baseline and post-intervention
Time frame: Baseline and pre- and post-intervention: 1) Lean Group-Baseline measures only; 2)Pre-Diabetic group - Baseline and 6-months post exercise intervention; 3) GBP group - Baseline and 3-months post Gastric Bypass Surgery
1. Lean Healthy Controls - Baseline only 2. Pre-Diabetic Group - Baseline and 6-months post the Aerobic and Resistance combined exercise training intervention 3. Gastric Bypass Group - Baseline and 3-months post Gastric Bypass surgery
1 secondary outcome
Changes in Insulin Sensitivity at Baseline and post-intervention
Time frame: Baseline and pre- and post-intervention: 1) Lean Group-Baseline measures only; 2)Pre-Diabetic group - Baseline and 6-months post exercise intervention; 3) GBP group - Baseline and 3-months post Gastric Bypass Surgery
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 19 Oct 2015.
- Derived from this study: PubMed 26254576Glynn EL, Piner LW, Huffman KM, Slentz CA, Elliot-Penry L, AbouAssi H, White PJ, Bain JR, Muehlbauer MJ, Ilkayeva OR, Stevens RD, Porter Starr KN, Bales CW, Volpi E, Brosnan MJ, Trimmer JK, Rolph TP, Newgard CB, Kraus WE. Impact of combined resistance and aerobic exercise training on branched-chain amino acid turnover, glycine metabolism and insulin sensitivity in overweight humans. Diabetologia. 2015 Oct;58(10):2324-35. doi: 10.1007/s00125-015-3705-6. Epub 2015 Aug 9.
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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.
William E. Kraus, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-Diabetes Group - 6-mo Aerobic and Resistance combined exercise training and GBP Group - Non-diabetics intending to undergo Gastric Bypass surgery in people with Branched-chain Amino Acid Metabolism and Insulin Sensitivity, run by Duke University 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 21 inclusion and 12 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 19 Oct 2015. 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?
Changes in Branched-chain Amino Acid Metabolism in Pre-Diabetes at Baseline and post-intervention (time frame: Baseline and pre- and post-intervention: 1) Lean Group-Baseline measures only; 2)Pre-Diabetic group - Baseline and 6-months post exercise intervention; 3) GBP group - Baseline and 3-months post Gastric Bypass Surgery). 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 NCT01786941, 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 19 Oct 2015.