Insulin ResistanceNCT02539355
Diet and Metabolic Inflammation
A study testing Diet A and Diet B in people with Insulin Resistance and Diabetes, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
Obesity is a risk factor for several common cancers, including those of the breast, colon, liver, and pancreas. Proposed molecular links between obesity and these types of cancer include systemic inflammation, hyperinsulinemia, and changes in the serum concentrations of sex steroid hormones and adipokines. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Diabetes, Cancer
- What is being tested?
- Diet A and Diet B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Sep 2016
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) ≥ 28 kg/m2
- Homeostasis model assessment insulin resistance (HOMA-IR) index > 2.0
- Body weight within 10% of weight 3 months before starting the study
- Able to come to the FHCRC Prevention Center for one 1-hour pre-study visit and two clinic visits of ~4.5 hours duration each
- Able and willing to attend bi-weekly dietary group counseling sessions at FHCRC during the 12-week intervention period
- Willingness and ability to follow the dietary regimen
Show all 10Show fewer
- Able to complete repeated 3-day food records before and during the dietary intervention.
- Willingness to maintain usual lifestyle habits (other than diet) throughout the study (e.g., physical activity habits)
- Ability to understand, speak, and write in English
- Ability to provide informed written consent
Who cannot join
- Any previous or current use of antidiabetic medications or insulin
- Presence or history of major chronic inflammatory or autoimmune disease (e.g., lupus, rheumatoid arthritis, Hashimoto's thyroiditis, inflammatory bowel disease, celiac disease, multiple sclerosis), malabsorption syndromes, or diseases of the liver, thyroid, or kidneys (stage IV or later chronic kidney disease)
- Food allergies or intolerances against major study foods
- Intake of drugs likely to interfere with study endpoints, including corticosteroids and anabolic steroids, hormone replacement therapy, NSAIDS (more than 3 times per week and/ or more than 600 mg per day), warfarin (within 3 months of starting the study), antibiotics or probiotics (within 2 weeks of starting the study)
- Presence or recent history of anemia (within 3 months of starting the study)
- Participation in another study that includes an intervention of any kind or a blood draw >300 mL over 3 months
Show all 9Show fewer
- Alcohol intake > 2 drinks per day
- Use of tobacco products, eCigarettes, or recreational drugs on more than 2 days per month
- Current or recent (within 12 months of starting the study) pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Obesity is a risk factor for several common cancers, including those of the breast, colon, liver, and pancreas. Proposed molecular links between obesity and these types of cancer include systemic inflammation, hyperinsulinemia, and changes in the serum concentrations of sex steroid hormones and adipokines. All of these are strongly linked to low-grade chronic inflammatory processes in expanded adipose tissue. The objective of this proposal is to test the hypothesis that adipose tissue inflammation can be reduced by the foods we eat.
Read the detailed description
Overweight or obese individuals with evidence of insulin resistance will be enrolled, until 16 have completed all study procedures. Enrolled subjects will be randomized to follow one of two healthy diets for 12 weeks to determine how each diet affects inflammation in the body and sugar and insulin levels in the blood.
We will address the following specific aims:
Primary specific aim: To investigate whether the consumption of either diet reduces the metabolic activation of adipose tissue macrophages (ATM) as assessed by quantifying the ATM cell surface expression (relative mean fluorescence intensity, rMFI) of the metabolic activation markers, CD36 and ABCA1.
Secondary specific aim 1: To compare how each of the study diets affects endpoints downstream of metabolic activation of ATM, specifically (a) adipose tissue expression of the key pro-inflammatory cytokines tumor necrosis factor α (TNFα) and interleukins (IL)-1 beta and 6; (b) adipose tissue expression of the key anti-inflammatory adipokine, adiponectin; (c) systemic insulin sensitivity, as assessed by the Matsuda-DeFronzo Insulin Sensitivity Index (ISI), based on a 3-hour frequently sampled oral glucose tolerance test (FS-OGTT); and oral glucose tolerance, as assessed by measuring the total area-under-the-curve glucose in the FS-OGTT.
Secondary specific aim 2: To compare the impact of each of the study diets on low-grade chronic systemic inflammation, as assessed by measuring the concentrations of high sensitivity C-reactive protein (hsCRP), IL-6, and total adiponectin in fasting plasma.
Secondary specific aim 3: To assess dietary adherence in the two dietary intervention groups. Dietary adherence will be measured by a dietary adherence score (separately for each diet), based on repeated 4-day diet records completed by all participants in the study.
Because all of our study endpoints are thought to be linked to the gut microbiota, and because the effects of diet may be mediated through changes in the gut microbiota, we will also collect stool samples from all participants before and after completing the study.
- Conditions
- Insulin Resistance, Diabetes, Cancer, Obesity, Inflammation
- Being tested
- Diet A, Diet B
- Keywords
- Insulin resistance, Diabetes, Cancer, Obesity, Inflammation
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Neoplasms, Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet AOther
12-week diet
Diet BOther
12-week Diet
| Study group | Role | What they receive |
|---|---|---|
| Diet A | Active comparator | Standard Healthy Diet (Diet A) Receives: Other: Diet A |
| Diet B | Experimental | Alternative Test Diet (Diet B) Receives: Other: Diet B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adipose tissue macrophage cell surface expression of metabolic activation marker CD36 as measured by relative mean fluorescence intensity
As measured by relative mean fluorescence intensity (rMFI) on abdominal subcutaneous adipose tissue macrophages
Measured: Change between beginning (day 1) and end (week 12) of the study diet period.
Change in adipose tissue macrophage cell surface expression of metabolic activation marker ABCA1 as measured by relative mean fluorescence intensity (rMFI)
As measured by relative mean fluorescence intensity (rMFI) on abdominal subcutaneous adipose tissue macrophages
Measured: Change between beginning (day 1) and end (week 12) of the study diet period.
Secondary outcomes (9)
Change in adipose tissue expression of the key pro-inflammatory cytokine, tumor necrosis factor α (TNFα) assessed by qPCR
Assessed by qPCR on whole abdominal subcutaneous adipose tissue
Measured: Change between beginning (day 1) and end (week 12) of the study diet period.
Change in adipose tissue expression of the key pro-inflammatory cytokine, interleukin-6 (IL-6) assessed by qPCR
Assessed by qPCR on whole abdominal subcutaneous adipose tissue
Measured: Change between beginning (day 1) and end (week 12) of the study diet period.
Change in adipose tissue expression of the key pro-inflammatory cytokine, interleukin-1 beta (IL-1beta) assessed by qPCR
Assessed by qPCR on whole abdominal subcutaneous adipose tissue
Measured: Change between beginning (day 1) and end (week 12) of the study diet period.
Change in adipose tissue expression of the key anti-inflammatory adipokine, adiponectin assessed by qPCR
Assessed by qPCR on whole abdominal subcutaneous adipose tissue
Measured: Change between beginning (day 1) and end (week 12) of the study diet period.
Change in systemic insulin sensitivity assessed by the Matsuda-DeFronzo Insulin Sensitivity Index
Assessed by the Matsuda-DeFronzo Insulin Sensitivity Index (ISI) based on a 3-hour frequently sampled oral glucose tolerance test (FS-OGTT)
Measured: Change between beginning (day 1) and end (week 12) of the study diet period.
Change in oral glucose tolerance assessed by measuring total area under the curve glucose in the FS-OGTT
Assessed by measuring total area under the curve glucose in the FS-OGTT
Measured: Change between beginning (day 1) and end (week 12) of the study diet period.
Change in fasting plasma C-reactive protein assessed by immunonephelometry
Assessed by immunonephelometry
Measured: Change between beginning (day 1) and end (week 12) of the study diet period.
Change in fasting plasma IL-6 assessed by high-sensitivity ELISA
Assessed by high-sensitivity ELISA
Measured: Change between beginning (day 1) and end (week 12) of the study diet period.
Change in fasting plasma total adiponectin assessed by ELISA
Assessed by ELISA
Measured: Change between beginning (day 1) and end (week 12) of the study diet period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Kratz, Fred Hutchinson Cancer Center
- Investigators
- Mario Kratz, PhD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539355
- Sponsor's protocol ID
- NCI2P30CA015704
- Other IDs
- CCSG Y39 Pilot: Kratz, M
- Status last verified
- Oct 2016
- First submitted
- 27 Aug 2015
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet and Metabolic Inflammation
- ClinicalTrials.gov ID
- NCT02539355
- Acronym / sponsor ID
- NCI2P30CA015704
- Conditions
- Insulin Resistance, Diabetes, Cancer, Obesity, Inflammation
- Keywords
- Insulin resistance, Diabetes, Cancer, Obesity, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 3 Sep 2015 (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.
Obesity is a risk factor for several common cancers, including those of the breast, colon, liver, and pancreas. Proposed molecular links between obesity and these types of cancer include systemic inflammation, hyperinsulinemia, and changes in the serum concentrations of sex steroid hormones and adipokines. All of these are strongly linked to low-grade chronic inflammatory processes in expanded adipose tissue. The objective of this proposal is to test the hypothesis that adipose tissue inflammation can be reduced by the foods we eat.
Detailed description
Overweight or obese individuals with evidence of insulin resistance will be enrolled, until 16 have completed all study procedures. Enrolled subjects will be randomized to follow one of two healthy diets for 12 weeks to determine how each diet affects inflammation in the body and sugar and insulin levels in the blood.
We will address the following specific aims:
Primary specific aim: To investigate whether the consumption of either diet reduces the metabolic activation of adipose tissue macrophages (ATM) as assessed by quantifying the ATM cell surface expression (relative mean fluorescence intensity, rMFI) of the metabolic activation markers, CD36 and ABCA1.
Secondary specific aim 1: To compare how each of the study diets affects endpoints downstream of metabolic activation of ATM, specifically (a) adipose tissue expression of the key pro-inflammatory cytokines tumor necrosis factor α (TNFα) and interleukins (IL)-1 beta and 6; (b) adipose tissue expression of the key anti-inflammatory adipokine, adiponectin; (c) systemic insulin sensitivity, as assessed by the Matsuda-DeFronzo Insulin Sensitivity Index (ISI), based on a 3-hour frequently sampled oral glucose tolerance test (FS-OGTT); and oral glucose tolerance, as assessed by measuring the total area-under-the-curve glucose in the FS-OGTT.
Secondary specific aim 2: To compare the impact of each of the study diets on low-grade chronic systemic inflammation, as assessed by measuring the concentrations of high sensitivity C-reactive protein (hsCRP), IL-6, and total adiponectin in fasting plasma.
Secondary specific aim 3: To assess dietary adherence in the two dietary intervention groups. Dietary adherence will be measured by a dietary adherence score (separately for each diet), based on repeated 4-day diet records completed by all participants in the study.
Because all of our study endpoints are thought to be linked to the gut microbiota, and because the effects of diet may be mediated through changes in the gut microbiota, we will also collect stool samples from all participants before and after completing the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet A | Active comparator | Other: Diet AStandard Healthy Diet (Diet A) |
| Diet B | Experimental | Other: Diet BAlternative Test Diet (Diet B) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Body Mass Index (BMI) ≥ 28 kg/m2
- Homeostasis model assessment insulin resistance (HOMA-IR) index > 2.0
- Body weight within 10% of weight 3 months before starting the study
- Able to come to the FHCRC Prevention Center for one 1-hour pre-study visit and two clinic visits of ~4.5 hours duration each
- Able and willing to attend bi-weekly dietary group counseling sessions at FHCRC during the 12-week intervention period
Key exclusion criteria (9 listed)
- Any previous or current use of antidiabetic medications or insulin
- Presence or history of major chronic inflammatory or autoimmune disease (e.g., lupus, rheumatoid arthritis, Hashimoto's thyroiditis, inflammatory bowel disease, celiac disease, multiple sclerosis), malabsorption syndromes, or diseases of the liver, thyroid, or kidneys (stage IV or later chronic kidney disease)
- Food allergies or intolerances against major study foods
- Intake of drugs likely to interfere with study endpoints, including corticosteroids and anabolic steroids, hormone replacement therapy, NSAIDS (more than 3 times per week and/ or more than 600 mg per day), warfarin (within 3 months of starting the study), antibiotics or probiotics (within 2 weeks of starting the study)
- Presence or recent history of anemia (within 3 months of starting the study)
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 |
|---|---|---|
| Diet A12-week diet | Other | Diet A |
| Diet B12-week Diet | Other | Diet B |
Primary outcome
Change in adipose tissue macrophage cell surface expression of metabolic activation marker CD36 as measured by relative mean fluorescence intensity
Time frame: Change between beginning (day 1) and end (week 12) of the study diet period.
As measured by relative mean fluorescence intensity (rMFI) on abdominal subcutaneous adipose tissue macrophages
Change in adipose tissue macrophage cell surface expression of metabolic activation marker ABCA1 as measured by relative mean fluorescence intensity (rMFI)
Time frame: Change between beginning (day 1) and end (week 12) of the study diet period.
As measured by relative mean fluorescence intensity (rMFI) on abdominal subcutaneous adipose tissue macrophages
9 secondary outcomes
Change in adipose tissue expression of the key pro-inflammatory cytokine, tumor necrosis factor α (TNFα) assessed by qPCR
Time frame: Change between beginning (day 1) and end (week 12) of the study diet period.
Change in adipose tissue expression of the key pro-inflammatory cytokine, interleukin-6 (IL-6) assessed by qPCR
Time frame: Change between beginning (day 1) and end (week 12) of the study diet period.
Change in adipose tissue expression of the key pro-inflammatory cytokine, interleukin-1 beta (IL-1beta) assessed by qPCR
Time frame: Change between beginning (day 1) and end (week 12) of the study diet period.
Change in adipose tissue expression of the key anti-inflammatory adipokine, adiponectin assessed by qPCR
Time frame: Change between beginning (day 1) and end (week 12) of the study diet period.
Change in systemic insulin sensitivity assessed by the Matsuda-DeFronzo Insulin Sensitivity Index
Time frame: Change between beginning (day 1) and end (week 12) of the study diet period.
Change in oral glucose tolerance assessed by measuring total area under the curve glucose in the FS-OGTT
Time frame: Change between beginning (day 1) and end (week 12) of the study diet period.
Change in fasting plasma C-reactive protein assessed by immunonephelometry
Time frame: Change between beginning (day 1) and end (week 12) of the study diet period.
Change in fasting plasma IL-6 assessed by high-sensitivity ELISA
Time frame: Change between beginning (day 1) and end (week 12) of the study diet period.
Change in fasting plasma total adiponectin assessed by ELISA
Time frame: Change between beginning (day 1) and end (week 12) of the study diet period.
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 24 Oct 2016.
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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.
Mario Kratz, PhD principal investigator
Fred Hutchinson Cancer 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 Diet A and Diet B in people with Insulin Resistance and Diabetes, run by Fred Hutchinson Cancer 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 10 inclusion and 9 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 24 Oct 2016. 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?
Change in adipose tissue macrophage cell surface expression of metabolic activation marker CD36 as measured by relative mean fluorescence intensity (time frame: Change between beginning (day 1) and end (week 12) of the study diet period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Oct 2016; AzTrials last refreshed its copy on 3 Nov 2026.