Insulin Resistance and Type 2 DiabetesNCT00795860
Fatty Acid Metabolism and Insulin Sensitivity: the Role of Endurance Exercise
A study testing Weight loss - diet only and Weight loss plus exercise in people with Insulin Resistance and Type 2 Diabetes, run by University of Michigan at 1 site in United States.
Trial summary
Clearly the effects of diet and exercise are beneficial for obese persons, but the underlying mechanisms for the improvements in metabolic health are not completely clear. Although mounting evidence suggests that alterations in lipid metabolism in persons with abdominal obesity are associated with a several medical… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance and Type 2 Diabetes
- What is being tested?
- Weight loss - diet only and Weight loss plus exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Jan 2007
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Age = 18-45
- Premenopausal
- Body mass index ≥ 30 kg/m2
- Waist circumference ≥ 100 cm
Who cannot join
- Evidence of metabolic or cardiovascular disease
- Pregnancy
- Allergies to soybeans or eggs
- Hyperlipidemia (fasting plasma triglyceride concentration > 125 mg/dl)
- Hematocrit < 34%
Trial locations and contacts
1 site in 1 country.
About this study
Clearly the effects of diet and exercise are beneficial for obese persons, but the underlying mechanisms for the improvements in metabolic health are not completely clear. Although mounting evidence suggests that alterations in lipid metabolism in persons with abdominal obesity are associated with a several medical complications, including diabetes, little is known about the factors responsible for this effect. The project in this application is designed to examine how the addition of endurance exercise training to a weight-loss program alters whole-body fatty acid availability, uptake, and oxidation as well as the expression of cellular factors that regulate these processes. In addition, we will evaluate whether these alterations are associated with improvements in insulin sensitivity. In the end, these experiments will provide insight into the cellular and whole-body adaptations in fatty acid metabolism in response to weight-loss and exercise training that may lead to enhancement of insulin sensitivity. Identifying relationships between gene expression, whole-body fatty acid metabolism and clinical outcome measurements, such as insulin sensitivity, may lead to improvements in the therapeutic and/or the preventative approach to obesity and its co-morbidities.
Read the detailed description
Despite robust findings emphasizing the importance of weight-loss and exercise for the prevention and management of insulin resistance and Type 2 diabetes, the mechanisms responsible for the improvements in metabolic health are not completely understood. Mounting evidence suggests that abnormalities in fatty acid metabolism in persons with abdominal obesity are associated with insulin resistance. Alterations in fatty acid mobilization and oxidation may be primary adaptations responsible for the improvements in metabolic health after weight-loss and endurance exercise training. We hypothesize that a disparity between muscle fatty acid uptake and oxidation is regulated by the expression of genes and proteins that participate in intracellular transport, trafficking, and metabolism of fatty acids. We believe that alterations in the expression of these factors in response to weight-loss and endurance exercise training will underlie changes in the non-oxidative disposal of fatty acids, and thereby improve insulin sensitivity. We will determine the effects of weight-loss and exercise training on whole-body fatty acid mobilization and oxidation and the expression of factors that regulate these processes in skeletal muscle. In addition, we will evaluate how these alterations are associated with improvements in insulin sensitivity. These studies will provide insight into how cellular alterations with weight-loss and exercise training and the accompanying changes in whole-body fatty acid metabolism may lead to improvements in metabolic health.
- Conditions
- Insulin Resistance and Type 2 Diabetes
- Being tested
- Weight loss - diet only, Weight loss plus exercise
- Keywords
- Insulin sensitivity, fat metabolism, inflammation
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 2, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss - diet onlyBehavioural
Subjects adhere to a reduced calorie diet until they lose exactly 12% of their initial body weight. After they achieve this weight loss goal, they are placed on a weight-maintaining diet for 3-4 weeks before follow-up experiments are performed. Subjects meet weekly with a research dietitian throughout their weigh-loss and weight maintenance program.
Weight loss plus exerciseBehavioural
Subjects adhere to a reduced calorie diet and perform 4 session of endurance exercise training per week until they lose exactly 12% of their initial body weight. Exercise training consists of stationary bicycle exercise. the exercise duration and intensity ramp up over the first few weeks of training until subjects exercise 45 min per session at an intensity of 85% of their maximal heart rate. 3 of the 4 exercise session each week are supervised by an Exercise physiologist. After they achieve the 12% weight loss goal, they are placed on a weight-maintaining diet for 3-4 weeks before follow-up experiments are performed. Subjects meet weekly with a research dietitian throughout their weigh-loss and weight maintenance program.
| Study group | Role | What they receive |
|---|---|---|
| Weight loss - diet only | Active comparator | Not described Receives: Behavioral: Weight loss - diet only |
| Weight loss plus exercise | Experimental | Not described Receives: Behavioral: Weight loss plus exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Measured: before and after 12% weight loss (3-6 months)
Secondary outcomes (3)
Rate of fatty acid mobilization in plasma
Measured: Before and after 12% weight loss (3-6 months)
Abundance and activity of Pro-inflammatory factors in skeletal muscle
Measured: Before and after 12% weight loss (3-6 months)
whole body and skeletal muscle oxidative capacity
Measured: Before and after 12% weight loss (3-6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startJun 2003
- Primary completionJan 2007
- Study completionJan 2007
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 Insulin Resistance and Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Jeffrey F Horowitz, University of Michigan
- Investigators
- Jeffrey Horowitz, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795860
- Sponsor's protocol ID
- ADA - 1-03-JF-10 (completed)
- Other IDs
- ADA grant# 1-03-JF-10
- Status last verified
- Oct 2017
- First submitted
- 20 Nov 2008
- Last updated
- 16 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schenk S, Horowitz JF. Coimmunoprecipitation of FAT/CD36 and CPT I in skeletal muscle increases proportionally with fat oxidation after endurance exercise training. Am J Physiol Endocrinol Metab. 2006 Aug;291(2):E254-60. doi: 10.1152/ajpendo.00051.2006. Epub 2006 May 2.
PubMed 16670153
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatty Acid Metabolism and Insulin Sensitivity: the Role of Endurance Exercise
- ClinicalTrials.gov ID
- NCT00795860
- Acronym / sponsor ID
- ADA - 1-03-JF-10 (completed)
- Conditions
- Insulin Resistance and Type 2 Diabetes
- Keywords
- Insulin sensitivity, fat metabolism, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- American Diabetes Association, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jun 2003 (actual)
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 21 Nov 2008 (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.
Clearly the effects of diet and exercise are beneficial for obese persons, but the underlying mechanisms for the improvements in metabolic health are not completely clear. Although mounting evidence suggests that alterations in lipid metabolism in persons with abdominal obesity are associated with a several medical complications, including diabetes, little is known about the factors responsible for this effect. The project in this application is designed to examine how the addition of endurance exercise training to a weight-loss program alters whole-body fatty acid availability, uptake, and oxidation as well as the expression of cellular factors that regulate these processes. In addition, we will evaluate whether these alterations are associated with improvements in insulin sensitivity. In the end, these experiments will provide insight into the cellular and whole-body adaptations in fatty acid metabolism in response to weight-loss and exercise training that may lead to enhancement of insulin sensitivity. Identifying relationships between gene expression, whole-body fatty acid metabolism and clinical outcome measurements, such as insulin sensitivity, may lead to improvements in the therapeutic and/or the preventative approach to obesity and its co-morbidities.
Detailed description
Despite robust findings emphasizing the importance of weight-loss and exercise for the prevention and management of insulin resistance and Type 2 diabetes, the mechanisms responsible for the improvements in metabolic health are not completely understood. Mounting evidence suggests that abnormalities in fatty acid metabolism in persons with abdominal obesity are associated with insulin resistance. Alterations in fatty acid mobilization and oxidation may be primary adaptations responsible for the improvements in metabolic health after weight-loss and endurance exercise training. We hypothesize that a disparity between muscle fatty acid uptake and oxidation is regulated by the expression of genes and proteins that participate in intracellular transport, trafficking, and metabolism of fatty acids. We believe that alterations in the expression of these factors in response to weight-loss and endurance exercise training will underlie changes in the non-oxidative disposal of fatty acids, and thereby improve insulin sensitivity. We will determine the effects of weight-loss and exercise training on whole-body fatty acid mobilization and oxidation and the expression of factors that regulate these processes in skeletal muscle. In addition, we will evaluate how these alterations are associated with improvements in insulin sensitivity. These studies will provide insight into how cellular alterations with weight-loss and exercise training and the accompanying changes in whole-body fatty acid metabolism may lead to improvements in metabolic health.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight loss - diet only | Active comparator | Behavioral: Weight loss - diet only |
| Weight loss plus exercise | Experimental | Behavioral: Weight loss plus exercise |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female
- Age = 18-45
- Premenopausal
- Body mass index ≥ 30 kg/m2
- Waist circumference ≥ 100 cm
Key exclusion criteria (5 listed)
- Evidence of metabolic or cardiovascular disease
- Pregnancy
- Allergies to soybeans or eggs
- Hyperlipidemia (fasting plasma triglyceride concentration > 125 mg/dl)
- Hematocrit < 34%
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 |
|---|---|---|
| Weight loss - diet onlySubjects adhere to a reduced calorie diet until they lose exactly 12% of their initial body weight. After they achieve this weight loss goal, they are placed on a weight-maintaining diet for 3-4 weeks before follow-up experiments are performed. Subjects meet weekly with a research dietitian throughout their weigh-loss and weight maintenance program. | Behavioural | Weight loss - diet only |
| Weight loss plus exerciseSubjects adhere to a reduced calorie diet and perform 4 session of endurance exercise training per week until they lose exactly 12% of their initial body weight. Exercise training consists of stationary bicycle exercise. the exercise duration and intensity ramp up over the first few weeks of training until subjects exercise 45 min per session at an intensity of 85% of their maximal heart rate. 3 of the 4 exercise session each week are supervised by an Exercise physiologist. After they achieve the 12% weight loss goal, they are placed on a weight-maintaining diet for 3-4 weeks before follow-up experiments are performed. Subjects meet weekly with a research dietitian throughout their weigh-loss and weight maintenance program. | Behavioural | Weight loss plus exercise |
Primary outcome
Insulin sensitivity
Time frame: before and after 12% weight loss (3-6 months)
3 secondary outcomes
Rate of fatty acid mobilization in plasma
Time frame: Before and after 12% weight loss (3-6 months)
Abundance and activity of Pro-inflammatory factors in skeletal muscle
Time frame: Before and after 12% weight loss (3-6 months)
whole body and skeletal muscle oxidative capacity
Time frame: Before and after 12% weight loss (3-6 months)
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 16 Oct 2017.
- Results publication: PubMed 16670153Schenk S, Horowitz JF. Coimmunoprecipitation of FAT/CD36 and CPT I in skeletal muscle increases proportionally with fat oxidation after endurance exercise training. Am J Physiol Endocrinol Metab. 2006 Aug;291(2):E254-60. doi: 10.1152/ajpendo.00051.2006. Epub 2006 May 2.
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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.
Jeffrey Horowitz, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight loss - diet only and Weight loss plus exercise in people with Insulin Resistance and Type 2 Diabetes, run by University of Michigan 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 5 inclusion and 5 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 16 Oct 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. 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?
Insulin sensitivity (time frame: before and after 12% weight loss (3-6 months)). 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 NCT00795860, 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 16 Oct 2017.