Newly Diagnosed Type 2 DiabetesNCT03832725
Pathobiology of Remission of Type 2 Diabetes
A study testing High Protein (HP) weight loss diet and High carbohydrate (HC) weight loss diet in people with Newly Diagnosed Type 2 Diabetes and Obese, run by University of Tennessee at 1 site in United States.
Trial summary
We propose to investigate effects of HP and HC weight loss diets in Newly Diagnosed T2DM (NT2DM) women and men for 6 months for remission of Type 2 Diabetes. Our long term goal is to establish a weight loss diet plan for remission of NT2DM which would be adaptable for use in physicians' clinics and metabolomics… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Newly Diagnosed Type 2 Diabetes, Obese
- What is being tested?
- High Protein (HP) weight loss diet and High carbohydrate (HC) weight loss diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 31 Jul 2024
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range 20 yrs to 50 yrs; ii) BMI > 30 kg/m2 to 55kg/m2; iii). Fasting blood glucose >126 mg/dl and 2 hour glucose >200 mg/dl determined by OGTT; iv). HbA1c > 6.5 % to ≤10%.
- -
Who cannot join
- Proteinuria or elevated serum creatinine (>1.5 mg/dl); ii) Surgical or premature menopause; iii) liver disease or abnormal liver function tests; iv) T2DM of greater than 2 yrs; v) Thyroid disease with abnormal TSH; vi) Weight > 350 lbs, (due to fit on DXA); vii) Triglycerides>400 mg/dl or LDL cholesterol >160 mg/dl; viii) SBP>145, DBP>100 mm of Hg; ix) on medications known to effect lipid or glucose metabolism; x) Pregnancy or become pregnant in next 6 mo; xi) Weight loss >10% of body weight in last 6 mo; xii)History of cancer <5 yrs or undergoing active treatment; xiii) smoking, xiv)alcohol abuse; xv) having CPAP treatment. xvi)Subjects with HbA1c >10% will be referred to an endocrinologist for pharmacological treatment.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Tennessee Health Science Center
Memphis, Tennessee, 38163
Frankie B Stentz, PhD, 901-448-5803, fstentz@uthsc.edu
About this study
We propose to investigate effects of HP and HC weight loss diets in Newly Diagnosed T2DM (NT2DM) women and men for 6 months for remission of Type 2 Diabetes. Our long term goal is to establish a weight loss diet plan for remission of NT2DM which would be adaptable for use in physicians' clinics and metabolomics predictors for assessment of remission. The overall objective of this study is to determine if remission of NT2DM can be induced by dietary manipulation using a HP diet and the pathobiology of this remission. We hypothesize that NT2DM subjects will have remission to NGT on the HP diet when they are provided the food and daily menus for compliance. The rationale is the HP diet is palatable for subjects to continue after the 6 month study and stay in remission using diet plans we provide. We will compare the effects of the HP vs HC diet on remission. Specific aims of this study are to determine the effects of the HP and HC diets on NT2DM obese subjects in a 6 month feeding study and determine: (a)remission of NT2DM to Normal Glucose Tolerance(NGT), (b)weight loss, (c)improvements in metabolic markers, Cardiovascular Risk Factors(CVR), and inflammation markers, and epigenetic DNA methylation changes and pathways involved with remission and metabolomic markers to establish predictive markers of remission of NT2DM. We propose to use a non-pharmaceutical means (HP diet) for remission of T2DM and weight loss and determine the pathobiology involved in improvement in metabolic and CVRs by interrogating the samples with emerging technologies. The proposed research is significant because if we can demonstrate the HP diet cause remission of NT2DM to NGT along with other metabolic improvements, it would be a significant improvement in health risk and medical cost to subjects.
Read the detailed description
Greater than 30 million people have diabetes. Over time diabetic patients need more and more medications and develop numerous medical complications. Remission of Type 2 Diabetes (T2DM) would have profound effects on people with diabetes with respect to overall health improvement (insulin sensitivity(Si), cardiovascular risk factors(CVR), inflammation markers (IC)), reduction of retinopathy, nephropathy, neuropathy and reduction in medical costs. Methods to accomplish this have not yet been determined, however, it is generally accepted that non-drug methods to treat T2DM is the most cost effective and have the fewest side effects. The primary risk factor for T2DM is obesity. Our randomized clinical trials comparing the effects of High Protein (HP) vs High Carbohydrate (HC) weight loss diets in obese, prediabetic(IGT) women and men where all foods were provided daily for 6 months(mo) showed that while both diet groups had similar weight loss, 100% of HP diet subjects had remission from IGT to Normal Glucose Tolerance(NGT), but only 33% of HC diet group had remission. Also, the HP diet provided greater improvement in Si, CVR, IC, and an increase in % lean body mass (LBM) compared to the HC diet demonstrating that weight loss is not the only factor involved in remission. Based on these findings, we now propose to investigate effects of HP and HC weight loss diets in Newly Diagnosed T2DM (NT2DM) women and men for 6 mo. Our long term goal is to establish a weight loss diet plan for remission of NT2DM which would be adaptable for use in physicians' clinics and metabolomics predictors for assess-ment of remission. The overall objective of this study is to determine if remission of NT2DM can be induced by dietary manipulation using a HP diet and the pathobiology of this remission. We hypothesize that NT2DM subjects will have remission to NGT on the HP diet when they are provided the food and daily menus for compliance. The rationale is the HP diet is palatable for subjects to continue after the 6 mo study and stay in remission using diet plans we provide. We will compare the effects of the HP vs HC diet on remission. Specific aims of this study are to determine the effects of the HP and HC diets on NT2DM obese subjects in a 6 mo feeding study and determine: (a)remission of NT2DM to NGT, (b)weight loss and LBM preservation, (c)improvements in metabolic markers, CVRs, IC, epigenetic DNA methylation changes and pathways involved with remission and metabolomic markers to establish predictive markers of remission of NT2DM. This study is innovative in that we propose to use a non-pharmaceutical means (HP diet) for remission of T2DM diabetes and weight loss and determine the pathobiology involved in improvement in metabolic and CVRs by interrogating the samples with emerging technologies. The proposed research is significant because if we can demonstrate the HP diet cause remission of NT2DM to NGT along with other metabolic improvements, it would be a significant improvement in health risk and medical cost to subjects
- Conditions
- Newly Diagnosed Type 2 Diabetes, Obese
- Being tested
- High Protein (HP) weight loss diet, High carbohydrate (HC) weight loss diet
- Keywords
- Type 2 Diabetes, obesity, pathobiology
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Protein (HP) weight loss dietOther
Newly diagnosed Type 2 Diabetic (NT2DM) subjects will be placed on a HP diet for 6 months with all food provided for weight loss and remission of NT2DM.
Intervention with the HP diet will be 6 months. If subjects have not had remission of Type 2 Diabetes by the end of the 6 months, they will be referred to an endocrinologist for pharmaceutical treatment
High carbohydrate (HC) weight loss dietOther
Newly diagnosed Type 2 Diabetic (NT2DM) subjects will be placed on a HC diet for 6 months with all food provided for weight loss and remission of NT2DM.
Intervention with the HP diet will be 6 months. If subjects have not had remission of Type 2 Diabetes by the end of the 6 months, they will be referred to an endocrinologist for pharmaceutical treatment
| Study group | Role | What they receive |
|---|---|---|
| High protein (HP) weight loss diet | Active comparator | A weight loss high protein (HP) (30% Kcal protein, 40% Kcal carbohydrate (CHO) and 30% Kcal fat) diet will be given to the subjects on that arm of study to pick up weekly for 6 months. Receives: Other: High Protein (HP) weight loss diet |
| High carbohydrate (HC) weight loss diet | Active comparator | A weight loss high carbohydrate (HC) (15% Kcal protein, 55% Kcal CHO and 30% Kcal fat) diet will be given to the subjects on that arm of study to pick up weekly for 6 months.
Intervention with the HC diet will be 6 months. If subjects have not had remission of Type 2 Diabetes by the end of the 6 months, they will be referred to an endocrinologist for pharmaceutical treatment Receives: Other: High carbohydrate (HC) weight loss diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission of Type 2 Diabetes
Remission of NT2DM to NGT will be determined by the OGTT ( a 75 gm glucose drink given at 0 minutes and then blood drawn to determine the glucose level at 2 hrs). This OGTT will be done at 3 and 6 months with the criteria of fasting glucose <126 mg/l and 2 hour glucose <140 mg/dl. Criteria for improvement from NT2DM to IGT will be fasting blood glucose <126 mg/dl and 2 hour glucose <199 mg/dl. At each weekly visit for food pick up the subject's glucose will be monitored for blood glucose changes from the start of the diet study. If subjects do not have remission of diabetes at 6 months, they will be referred to an endocrinologist for possible pharmacology treatment.
Measured: Each subject will be monitored for 6 months while they are on the HP or HC diet for remission of Type 2 Diabetes
Secondary outcomes (4)
Weight loss
Determine changes in weight loss changes in inflammation markers such as cytokines, changes in incretins and determine metabolom markers for diagnosis of remission of NT2DM over the 6 months of the study
Measured: Each subject will be monitored for 6 months while they are on the HP or HC diet
Cardiovascular Risk Factors (CVR)
Changes in CVR will be determined by changes in blood pressure (systolic/diastolic) from the start of the diet to the end of the 6 month diet study.
Measured: Each subject will be monitored for 6 months while they are on the HP or HC diet
Inflammation markers such as cytokines,
Changes in inflammation markers in the subjects' blood such as cytokines
Measured: Each subject will be monitored for 6 months while they are on the HP or HC diet
Metabolom Markers
Changes in Metabolom Markers will be measured to determine changes from the start of the study to the end of the 6 months for possible markers of remission diabetes
Measured: Each subject will be monitored for 6 months while they are on the HP or HC diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start1 Mar 2018
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed 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
- Parallel groups
- Model description
- Subjects will be randomized to a macronutrient high protein or high carbohydrate diet provided by the study for weight loss and remission of Type 2 Diabetes
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frankie Stentz, University of Tennessee
- Investigators
- Frankie B Stentz, PhD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832725
- Sponsor's protocol ID
- UTennHSCFS
- Status last verified
- Feb 2019
- First submitted
- 1 Feb 2019
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and informed consent will be shared. Data at the end of the study will be reported. No patient identification will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathobiology of Remission of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03832725
- Acronym / sponsor ID
- UTennHSCFS
- Conditions
- Newly Diagnosed Type 2 Diabetes, Obese
- Keywords
- Type 2 Diabetes, obesity, pathobiology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 6 Feb 2019 (actual)
- 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.
We propose to investigate effects of HP and HC weight loss diets in Newly Diagnosed T2DM (NT2DM) women and men for 6 months for remission of Type 2 Diabetes. Our long term goal is to establish a weight loss diet plan for remission of NT2DM which would be adaptable for use in physicians' clinics and metabolomics predictors for assessment of remission. The overall objective of this study is to determine if remission of NT2DM can be induced by dietary manipulation using a HP diet and the pathobiology of this remission. We hypothesize that NT2DM subjects will have remission to NGT on the HP diet when they are provided the food and daily menus for compliance. The rationale is the HP diet is palatable for subjects to continue after the 6 month study and stay in remission using diet plans we provide. We will compare the effects of the HP vs HC diet on remission. Specific aims of this study are to determine the effects of the HP and HC diets on NT2DM obese subjects in a 6 month feeding study and determine: (a)remission of NT2DM to Normal Glucose Tolerance(NGT), (b)weight loss, (c)improvements in metabolic markers, Cardiovascular Risk Factors(CVR), and inflammation markers, and epigenetic DNA methylation changes and pathways involved with remission and metabolomic markers to establish predictive markers of remission of NT2DM. We propose to use a non-pharmaceutical means (HP diet) for remission of T2DM and weight loss and determine the pathobiology involved in improvement in metabolic and CVRs by interrogating the samples with emerging technologies. The proposed research is significant because if we can demonstrate the HP diet cause remission of NT2DM to NGT along with other metabolic improvements, it would be a significant improvement in health risk and medical cost to subjects.
Detailed description
Greater than 30 million people have diabetes. Over time diabetic patients need more and more medications and develop numerous medical complications. Remission of Type 2 Diabetes (T2DM) would have profound effects on people with diabetes with respect to overall health improvement (insulin sensitivity(Si), cardiovascular risk factors(CVR), inflammation markers (IC)), reduction of retinopathy, nephropathy, neuropathy and reduction in medical costs. Methods to accomplish this have not yet been determined, however, it is generally accepted that non-drug methods to treat T2DM is the most cost effective and have the fewest side effects. The primary risk factor for T2DM is obesity. Our randomized clinical trials comparing the effects of High Protein (HP) vs High Carbohydrate (HC) weight loss diets in obese, prediabetic(IGT) women and men where all foods were provided daily for 6 months(mo) showed that while both diet groups had similar weight loss, 100% of HP diet subjects had remission from IGT to Normal Glucose Tolerance(NGT), but only 33% of HC diet group had remission. Also, the HP diet provided greater improvement in Si, CVR, IC, and an increase in % lean body mass (LBM) compared to the HC diet demonstrating that weight loss is not the only factor involved in remission. Based on these findings, we now propose to investigate effects of HP and HC weight loss diets in Newly Diagnosed T2DM (NT2DM) women and men for 6 mo. Our long term goal is to establish a weight loss diet plan for remission of NT2DM which would be adaptable for use in physicians' clinics and metabolomics predictors for assess-ment of remission. The overall objective of this study is to determine if remission of NT2DM can be induced by dietary manipulation using a HP diet and the pathobiology of this remission. We hypothesize that NT2DM subjects will have remission to NGT on the HP diet when they are provided the food and daily menus for compliance. The rationale is the HP diet is palatable for subjects to continue after the 6 mo study and stay in remission using diet plans we provide. We will compare the effects of the HP vs HC diet on remission. Specific aims of this study are to determine the effects of the HP and HC diets on NT2DM obese subjects in a 6 mo feeding study and determine: (a)remission of NT2DM to NGT, (b)weight loss and LBM preservation, (c)improvements in metabolic markers, CVRs, IC, epigenetic DNA methylation changes and pathways involved with remission and metabolomic markers to establish predictive markers of remission of NT2DM. This study is innovative in that we propose to use a non-pharmaceutical means (HP diet) for remission of T2DM diabetes and weight loss and determine the pathobiology involved in improvement in metabolic and CVRs by interrogating the samples with emerging technologies. The proposed research is significant because if we can demonstrate the HP diet cause remission of NT2DM to NGT along with other metabolic improvements, it would be a significant improvement in health risk and medical cost to subjects
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Subjects will be randomized to a macronutrient high protein or high carbohydrate diet provided by the study for weight loss and remission of Type 2 Diabetes
| Arm | Type | Receives |
|---|---|---|
| High protein (HP) weight loss diet | Active comparator | Other: High Protein (HP) weight loss dietA weight loss high protein (HP) (30% Kcal protein, 40% Kcal carbohydrate (CHO) and 30% Kcal fat) diet will be given to the subjects on that arm of study to pick up weekly for 6 months. |
| High carbohydrate (HC) weight loss diet | Active comparator | Other: High carbohydrate (HC) weight loss dietA weight loss high carbohydrate (HC) (15% Kcal protein, 55% Kcal CHO and 30% Kcal fat) diet will be given to the subjects on that arm of study to pick up weekly for 6 months. Intervention with the HC diet will be 6 months. If subjects have not had remission of Type 2 Diabetes by the end of the 6 months, they will be referred to an endocrinologist for pharmaceutical treatment |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age range 20 yrs to 50 yrs; ii) BMI > 30 kg/m2 to 55kg/m2; iii). Fasting blood glucose >126 mg/dl and 2 hour glucose >200 mg/dl determined by OGTT; iv). HbA1c > 6.5 % to ≤10%.
- -
Key exclusion criteria (2 listed)
- Proteinuria or elevated serum creatinine (>1.5 mg/dl); ii) Surgical or premature menopause; iii) liver disease or abnormal liver function tests; iv) T2DM of greater than 2 yrs; v) Thyroid disease with abnormal TSH; vi) Weight > 350 lbs, (due to fit on DXA); vii) Triglycerides>400 mg/dl or LDL cholesterol >160 mg/dl; viii) SBP>145, DBP>100 mm of Hg; ix) on medications known to effect lipid or glucose metabolism; x) Pregnancy or become pregnant in next 6 mo; xi) Weight loss >10% of body weight in last 6 mo; xii)History of cancer <5 yrs or undergoing active treatment; xiii) smoking, xiv)alcohol abuse; xv) having CPAP treatment. xvi)Subjects with HbA1c >10% will be referred to an endocrinologist for pharmacological treatment.
- -
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 |
|---|---|---|
| High Protein (HP) weight loss dietNewly diagnosed Type 2 Diabetic (NT2DM) subjects will be placed on a HP diet for 6 months with all food provided for weight loss and remission of NT2DM. Intervention with the HP diet will be 6 months. If subjects have not had remission of Type 2 Diabetes by the end of the 6 months, they will be referred to an endocrinologist for pharmaceutical treatment | Other | High protein (HP) weight loss diet |
| High carbohydrate (HC) weight loss dietNewly diagnosed Type 2 Diabetic (NT2DM) subjects will be placed on a HC diet for 6 months with all food provided for weight loss and remission of NT2DM. Intervention with the HP diet will be 6 months. If subjects have not had remission of Type 2 Diabetes by the end of the 6 months, they will be referred to an endocrinologist for pharmaceutical treatment | Other | High carbohydrate (HC) weight loss diet |
Primary outcome
Remission of Type 2 Diabetes
Time frame: Each subject will be monitored for 6 months while they are on the HP or HC diet for remission of Type 2 Diabetes
Remission of NT2DM to NGT will be determined by the OGTT ( a 75 gm glucose drink given at 0 minutes and then blood drawn to determine the glucose level at 2 hrs). This OGTT will be done at 3 and 6 months with the criteria of fasting glucose <126 mg/l and 2 hour glucose <140 mg/dl. Criteria for improvement from NT2DM to IGT will be fasting blood glucose <126 mg/dl and 2 hour glucose <199 mg/dl. At each weekly visit for food pick up the subject's glucose will be monitored for blood glucose changes from the start of the diet study. If subjects do not have remission of diabetes at 6 months, they will be referred to an endocrinologist for possible pharmacology treatment.
4 secondary outcomes
Weight loss
Time frame: Each subject will be monitored for 6 months while they are on the HP or HC diet
Cardiovascular Risk Factors (CVR)
Time frame: Each subject will be monitored for 6 months while they are on the HP or HC diet
Inflammation markers such as cytokines,
Time frame: Each subject will be monitored for 6 months while they are on the HP or HC diet
Metabolom Markers
Time frame: Each subject will be monitored for 6 months while they are on the HP or HC diet
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
- Individual participant dataSharing planned: Yes. Study protocol and informed consent will be shared. Data at the end of the study will be reported. No patient identification will be shared.
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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.
Frankie B Stentz, PhD principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Protein (HP) weight loss diet and High carbohydrate (HC) weight loss diet in people with Newly Diagnosed Type 2 Diabetes and Obese, run by University of Tennessee 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Feb 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frankie B Stentz, PhD (901-448-5803, fstentz@uthsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission of Type 2 Diabetes (time frame: Each subject will be monitored for 6 months while they are on the HP or HC diet for remission of Type 2 Diabetes). 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 7 Feb 2019.