PrediabetesPROP-ABCNCT02027571
Pathobiology and Reversibility of Prediabetes in a Biracial Cohort
A study testing Intensive Lifestyle Intervention (ILI) in people with Prediabetes and Type 2 Diabetes, run by University of Tennessee at 1 site in United States.
Trial summary
The reasons for the epidemics of diabetes and prediabetes, and why individuals from certain populations suffer at higher rates are not well known. In the Pathobiology and Reversibility of Prediabetes in a Biracial Cohort (PROP-ABC) study, nearly 400 African Americans and Caucasians whose parents have type 2 diabetes… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Prediabetes, Type 2 Diabetes, Obesity
- What is being tested?
- Intensive Lifestyle Intervention (ILI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Oct 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- As planned these studies will enroll interested persons from among the group of 376 subjects who participated in the Pathobiology of Prediabetes in a Biracial Cohort (POP-ABC) study between 2006 and 2012. That group includes 267 women and 109 men; 217 are African Americans and 159 are Caucasians. At the time of initial enrollment into POP-ABC, these participants were selected for being nondiabetic offspring of parents with type 2 diabetes. Race and ethnicity was by self-report of non-Hispanic white or non-Hispanic black heritage, and their age range was 18-65 years at enrollment. No new subjects will be recruited into this established cohort. To be eligible for inclusion in the renewal study, subjects must be ambulatory, be in good general health, and must not be taking medications known to alter insulin sensitivity, insulin secretion, or body weight.
Who cannot join
- Exclusion criteria: Persons not enrolled in POP-ABC study; diagnosis of diabetes or use of any antidiabetic medication; medical conditions that preclude participation in physical activity; history of liposuction, surgical weight reduction; use of glucocorticoids, beta-blockers, thiazide diuretics (> 25 mg/day), or medication known to alter glucose metabolism. Women who are pregnant or become pregnant while participating in this study will have all testing procedures delayed until 12 months after delivery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Center, University of Tennessee Health Scienc Ctr
Memphis, Tennessee, 38104
About this study
Official title: Pathobiology and Reversibility of Prediabetes in a Biracial Cohort (PROP-ABC)
The reasons for the epidemics of diabetes and prediabetes, and why individuals from certain populations suffer at higher rates are not well known. In the Pathobiology and Reversibility of Prediabetes in a Biracial Cohort (PROP-ABC) study, nearly 400 African Americans and Caucasians whose parents have type 2 diabetes will undergo repeated testing to determine what factors lead to the occurrence of prediabetes, and whether race still plays a major role in a setting where everyone being studied has one or both parents with diabetes. The PROP-ABC Study also will test the hypothesis that the ability of intensive lifestyle intervention to reverse prediabetes and return people's metabolism back to normal is dependent on how long people have had prediabetes.
Read the detailed description
The Pathobiology and Reversibility of Prediabetes in a Biracial Cohort (PROP-ABC) study is following an extant cohort of 376 initially normoglycemic African American and Caucasian offspring of parents with type 2 diabetes for an additional 5years. The subjects were enrolled between 2006 and 2009 and have been followed up to 2012, during which 10 have developed diabetes and 101 developed prediabetes, without evidence of racial disparities.
The objectives of PROP-ABC are to gain a fuller understanding of the natural history and predictors of early glucose abnormalities, determine the role of race during the second wave of glycemic progression, and to access the time dependency of reversibility of prediabetes. The study tests 4 hypotheses: 1) Among offspring of parents with type 2 diabetes, early progression from normal to impaired glucose regulation (within 5 yr) occurs in the highest-risk subjects independently of race, whereas late progression (5-10 yr) displays racial disparities, and is predicted by physiological, biochemical and behavioral markers; 2) Early microvascular complications, peripheral vascular disease (PVD), and endothelial dysfunction manifest during transition from normal to impaired glucose regulation, display racial disparities, and are predicted by glycemic and nonglycemic factors; 3) The "metabolically healthy" insulin-sensitive obese (ISO) phenotype displays racial disparities in its association with cardiometabolic risk factors and incident dysglycemia among African-Americans and Caucasians offspring of parents with type 2 diabetes; and 4) Duration of the prediabetic state is a major determinant of, and is inversely related to, the efficacy of lifestyle intervention to induce regression of the prediabetic phenotype and restoration of normal glucose regulation. Participants with prediabetes and others who develop prediabetes during PROP-ABC will receive Intensive Lifestyle intervention (ILI).
We define duration of prediabetes as the interval from date of confirmed prediabetes to the date of initiation of ILI, stratified to 3 prediabetes intervals: a) <1 yr, b) 1 to <3 yr, c) 3-6 yr. The primary outcome measure is restoration of normal glucose regulation (fasting plasma glucose <100 mg/dl and 2-hour post-load plasma glucose < 140 mg/dl). Secondary endpoints include normalization of either fasting plasma glucose or 2-hour post-load plasma glucose , occurrence of diabetes, insulin sensitivity and secretion. Data will be analyzed according to the "intention to treat" principle. Based on power calculations, a sample size of 150 subjects (50/prediabetes interval) would allow detection of medium to large effect off ILI with ~85% power. Kaplan-Meier survival curves will be generated for the 3 prediabetes intervals, and log-rank test will be used to analyze the time to occurrence of primary outcome. The prospective PROP-ABC, designed to identify new cases of prediabetes as they occur, is uniquely placed to test the time dependency of reversibility of incident prediabetes.
- Conditions
- Prediabetes, Type 2 Diabetes, Obesity
- Being tested
- Intensive Lifestyle Intervention (ILI)
- Keywords
- Diabetes, Race/Ethnicity, Offspring Cohort, African Americans, Prediabetes Reversal, Lifestyle Intervention, Insulin Sensitivity, Beta-cell Function, Diabetes Prevention
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Type 2, Obesity, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Lifestyle Intervention (ILI)Behavioural
ILI consists of weight loss ( > 10%); caloric reduction; physical activity (180 min/week); monthly visits for group counseling for 6 months, followed by quarterly visits; and meal replacements.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Lifestyle Intervention (ILI) | Experimental | ILI consists of weight loss ( > 10%); caloric reduction; physical activity (180 min/week); monthly visits for group counseling for 6 months, followed by quarterly visits; and meal replacements. Receives: Behavioral: Intensive Lifestyle Intervention (ILI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is restoration of normal glucose regulation
The primary outcome measure is restoration of normal glucose regulation (FPG <100 mg/dl and 2hrPG < 140 mg/dl).
Measured: Up to 60 months
Secondary outcomes (1)
Glucose normalization
Secondary endpoints include normalization of either fasting plasma glucose or 2-hr OGTT plasma glucose levels, occurrence of diabetes, insulin sensitivity and secretion.
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startOct 2013
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for PrediabetesStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Dagogo-Jack, MD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027571
- Sponsor's protocol ID
- IRB Number: 12-01970-FB
- Other IDs
- R01DK067269
- Acronym
- PROP-ABC
- Status last verified
- Oct 2016
- First submitted
- 2 Jan 2014
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Group data will be published after completion of study and analysis of results. Individual participant-level information will not be shared.
Publications
Dagogo-Jack S, Edeoga C, Ebenibo S, Chapp-Jumbo E; Pathobiology of Prediabetes in a Biracial Cohort (POP-ABC) Research Group. Pathobiology of Prediabetes in a Biracial Cohort (POP-ABC) study: baseline characteristics of enrolled subjects. J Clin Endocrinol Metab. 2013 Jan;98(1):120-8. doi: 10.1210/jc.2012-2902. Epub 2012 Nov 1.
PubMed 23118422Ebenibo S, Edeoga C, Ammons A, Egbuonu N, Dagogo-Jack S; Pathobiology of Prediabetes in a Biracial Cohort (POP-ABC) Research Group. Recruitment strategies and yields for the Pathobiology of Prediabetes in a Biracial Cohort: a prospective natural history study of incident dysglycemia. BMC Med Res Methodol. 2013 May 10;13:64. doi: 10.1186/1471-2288-13-64.
PubMed 23663750Dagogo-Jack S, Edeoga C, Ebenibo S, Nyenwe E, Wan J; Pathobiology of Prediabetes in a Biracial Cohort (POP-ABC) Research Group. Lack of racial disparity in incident prediabetes and glycemic progression among black and white offspring of parents with type 2 diabetes: the pathobiology of prediabetes in a biracial cohort (POP-ABC) study. J Clin Endocrinol Metab. 2014 Jun;99(6):E1078-87. doi: 10.1210/jc.2014-1077. Epub 2014 Mar 14.
PubMed 24628558Owei I, Umekwe N, Wan J, Dagogo-Jack S. Plasma lipid levels predict dysglycemia in a biracial cohort of nondiabetic subjects: Potential mechanisms. Exp Biol Med (Maywood). 2016 Nov;241(17):1961-1967. doi: 10.1177/1535370216659946. Epub 2016 Jul 17.
PubMed 27430991Nyenwe E, Owei I, Wan J, Dagogo-Jack S. Parental History of Type 2 Diabetes Abrogates Ethnic Disparities in Key Glucoregulatory Indices. J Clin Endocrinol Metab. 2018 Feb 1;103(2):514-522. doi: 10.1210/jc.2017-01895.
PubMed 29216357Edeoga C, Owei I, Siwakoti K, Umekwe N, Ceesay F, Wan J, Dagogo-Jack S. Relationships between blood pressure and blood glucose among offspring of parents with type 2 diabetes: Prediction of incident dysglycemia in a biracial cohort. J Diabetes Complications. 2017 Nov;31(11):1580-1586. doi: 10.1016/j.jdiacomp.2017.07.019. Epub 2017 Aug 2.
PubMed 28890305Owei I, Umekwe N, Mohamed H, Ebenibo S, Wan J, Dagogo-Jack S. Ethnic Disparities in Endothelial Function and Its Cardiometabolic Correlates: The Pathobiology of Prediabetes in A Biracial Cohort Study. Front Endocrinol (Lausanne). 2018 Mar 13;9:94. doi: 10.3389/fendo.2018.00094. eCollection 2018.
PubMed 29593654Owei I, Umekwe N, Provo C, Wan J, Dagogo-Jack S. Insulin-sensitive and insulin-resistant obese and non-obese phenotypes: role in prediction of incident pre-diabetes in a longitudinal biracial cohort. BMJ Open Diabetes Res Care. 2017 Jul 19;5(1):e000415. doi: 10.1136/bmjdrc-2017-000415. eCollection 2017.
PubMed 28878939Dagogo-Jack S, Umekwe N, Brewer AA, Owei I, Mupparaju V, Rosenthal R, Wan J. Outcome of lifestyle intervention in relation to duration of pre-diabetes: the Pathobiology and Reversibility of Prediabetes in a Biracial Cohort (PROP-ABC) study. BMJ Open Diabetes Res Care. 2022 Mar;10(2):e002748. doi: 10.1136/bmjdrc-2021-002748.
PubMed 35273012Dagogo-Jack S, Brewer AA, Owei I, French L, Umekwe N, Rosenthal R, Wan J. Pathobiology and Reversibility of Prediabetes in a Biracial Cohort (PROP-ABC) Study: design of lifestyle intervention. BMJ Open Diabetes Res Care. 2020 Jun;8(1):e000899. doi: 10.1136/bmjdrc-2019-000899.
PubMed 32527719
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathobiology and Reversibility of Prediabetes in a Biracial Cohort (PROP-ABC)
- ClinicalTrials.gov ID
- NCT02027571
- Acronym / sponsor ID
- PROP-ABC / IRB Number: 12-01970-FB
- Conditions
- Prediabetes, Type 2 Diabetes, Obesity
- Keywords
- Diabetes, Race/Ethnicity, Offspring Cohort, African Americans, Prediabetes Reversal, Lifestyle Intervention, Insulin Sensitivity, Beta-cell Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Oct 2013 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 6 Jan 2014 (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 reasons for the epidemics of diabetes and prediabetes, and why individuals from certain populations suffer at higher rates are not well known. In the Pathobiology and Reversibility of Prediabetes in a Biracial Cohort (PROP-ABC) study, nearly 400 African Americans and Caucasians whose parents have type 2 diabetes will undergo repeated testing to determine what factors lead to the occurrence of prediabetes, and whether race still plays a major role in a setting where everyone being studied has one or both parents with diabetes. The PROP-ABC Study also will test the hypothesis that the ability of intensive lifestyle intervention to reverse prediabetes and return people's metabolism back to normal is dependent on how long people have had prediabetes.
Detailed description
The Pathobiology and Reversibility of Prediabetes in a Biracial Cohort (PROP-ABC) study is following an extant cohort of 376 initially normoglycemic African American and Caucasian offspring of parents with type 2 diabetes for an additional 5years. The subjects were enrolled between 2006 and 2009 and have been followed up to 2012, during which 10 have developed diabetes and 101 developed prediabetes, without evidence of racial disparities.
The objectives of PROP-ABC are to gain a fuller understanding of the natural history and predictors of early glucose abnormalities, determine the role of race during the second wave of glycemic progression, and to access the time dependency of reversibility of prediabetes. The study tests 4 hypotheses: 1) Among offspring of parents with type 2 diabetes, early progression from normal to impaired glucose regulation (within 5 yr) occurs in the highest-risk subjects independently of race, whereas late progression (5-10 yr) displays racial disparities, and is predicted by physiological, biochemical and behavioral markers; 2) Early microvascular complications, peripheral vascular disease (PVD), and endothelial dysfunction manifest during transition from normal to impaired glucose regulation, display racial disparities, and are predicted by glycemic and nonglycemic factors; 3) The "metabolically healthy" insulin-sensitive obese (ISO) phenotype displays racial disparities in its association with cardiometabolic risk factors and incident dysglycemia among African-Americans and Caucasians offspring of parents with type 2 diabetes; and 4) Duration of the prediabetic state is a major determinant of, and is inversely related to, the efficacy of lifestyle intervention to induce regression of the prediabetic phenotype and restoration of normal glucose regulation. Participants with prediabetes and others who develop prediabetes during PROP-ABC will receive Intensive Lifestyle intervention (ILI).
We define duration of prediabetes as the interval from date of confirmed prediabetes to the date of initiation of ILI, stratified to 3 prediabetes intervals: a) <1 yr, b) 1 to <3 yr, c) 3-6 yr. The primary outcome measure is restoration of normal glucose regulation (fasting plasma glucose <100 mg/dl and 2-hour post-load plasma glucose < 140 mg/dl). Secondary endpoints include normalization of either fasting plasma glucose or 2-hour post-load plasma glucose , occurrence of diabetes, insulin sensitivity and secretion. Data will be analyzed according to the "intention to treat" principle. Based on power calculations, a sample size of 150 subjects (50/prediabetes interval) would allow detection of medium to large effect off ILI with ~85% power. Kaplan-Meier survival curves will be generated for the 3 prediabetes intervals, and log-rank test will be used to analyze the time to occurrence of primary outcome. The prospective PROP-ABC, designed to identify new cases of prediabetes as they occur, is uniquely placed to test the time dependency of reversibility of incident prediabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intensive Lifestyle Intervention (ILI) | Experimental | Behavioral: Intensive Lifestyle Intervention (ILI)ILI consists of weight loss ( > 10%); caloric reduction; physical activity (180 min/week); monthly visits for group counseling for 6 months, followed by quarterly visits; and meal replacements. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- As planned these studies will enroll interested persons from among the group of 376 subjects who participated in the Pathobiology of Prediabetes in a Biracial Cohort (POP-ABC) study between 2006 and 2012. That group includes 267 women and 109 men; 217 are African Americans and 159 are Caucasians. At the time of initial enrollment into POP-ABC, these participants were selected for being nondiabetic offspring of parents with type 2 diabetes. Race and ethnicity was by self-report of non-Hispanic white or non-Hispanic black heritage, and their age range was 18-65 years at enrollment. No new subjects will be recruited into this established cohort. To be eligible for inclusion in the renewal study, subjects must be ambulatory, be in good general health, and must not be taking medications known to alter insulin sensitivity, insulin secretion, or body weight.
Key exclusion criteria (1 listed)
- Exclusion criteria: Persons not enrolled in POP-ABC study; diagnosis of diabetes or use of any antidiabetic medication; medical conditions that preclude participation in physical activity; history of liposuction, surgical weight reduction; use of glucocorticoids, beta-blockers, thiazide diuretics (> 25 mg/day), or medication known to alter glucose metabolism. Women who are pregnant or become pregnant while participating in this study will have all testing procedures delayed until 12 months after delivery.
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 |
|---|---|---|
| Intensive Lifestyle Intervention (ILI)ILI consists of weight loss ( > 10%); caloric reduction; physical activity (180 min/week); monthly visits for group counseling for 6 months, followed by quarterly visits; and meal replacements. | Behavioural | Intensive Lifestyle Intervention (ILI) |
Primary outcome
The primary outcome measure is restoration of normal glucose regulation
Time frame: Up to 60 months
The primary outcome measure is restoration of normal glucose regulation (FPG <100 mg/dl and 2hrPG < 140 mg/dl).
1 secondary outcome
Glucose normalization
Time frame: Up to 60 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 15 Oct 2018.
- Background: PubMed 23118422Dagogo-Jack S, Edeoga C, Ebenibo S, Chapp-Jumbo E; Pathobiology of Prediabetes in a Biracial Cohort (POP-ABC) Research Group. Pathobiology of Prediabetes in a Biracial Cohort (POP-ABC) study: baseline characteristics of enrolled subjects. J Clin Endocrinol Metab. 2013 Jan;98(1):120-8. doi: 10.1210/jc.2012-2902. Epub 2012 Nov 1.
- Background: PubMed 23663750Ebenibo S, Edeoga C, Ammons A, Egbuonu N, Dagogo-Jack S; Pathobiology of Prediabetes in a Biracial Cohort (POP-ABC) Research Group. Recruitment strategies and yields for the Pathobiology of Prediabetes in a Biracial Cohort: a prospective natural history study of incident dysglycemia. BMC Med Res Methodol. 2013 May 10;13:64. doi: 10.1186/1471-2288-13-64.
- Background: PubMed 24628558Dagogo-Jack S, Edeoga C, Ebenibo S, Nyenwe E, Wan J; Pathobiology of Prediabetes in a Biracial Cohort (POP-ABC) Research Group. Lack of racial disparity in incident prediabetes and glycemic progression among black and white offspring of parents with type 2 diabetes: the pathobiology of prediabetes in a biracial cohort (POP-ABC) study. J Clin Endocrinol Metab. 2014 Jun;99(6):E1078-87. doi: 10.1210/jc.2014-1077. Epub 2014 Mar 14.
- Background: PubMed 27430991Owei I, Umekwe N, Wan J, Dagogo-Jack S. Plasma lipid levels predict dysglycemia in a biracial cohort of nondiabetic subjects: Potential mechanisms. Exp Biol Med (Maywood). 2016 Nov;241(17):1961-1967. doi: 10.1177/1535370216659946. Epub 2016 Jul 17.
- Background: PubMed 29216357Nyenwe E, Owei I, Wan J, Dagogo-Jack S. Parental History of Type 2 Diabetes Abrogates Ethnic Disparities in Key Glucoregulatory Indices. J Clin Endocrinol Metab. 2018 Feb 1;103(2):514-522. doi: 10.1210/jc.2017-01895.
- Background: PubMed 28890305Edeoga C, Owei I, Siwakoti K, Umekwe N, Ceesay F, Wan J, Dagogo-Jack S. Relationships between blood pressure and blood glucose among offspring of parents with type 2 diabetes: Prediction of incident dysglycemia in a biracial cohort. J Diabetes Complications. 2017 Nov;31(11):1580-1586. doi: 10.1016/j.jdiacomp.2017.07.019. Epub 2017 Aug 2.
- Results publication: PubMed 29593654Owei I, Umekwe N, Mohamed H, Ebenibo S, Wan J, Dagogo-Jack S. Ethnic Disparities in Endothelial Function and Its Cardiometabolic Correlates: The Pathobiology of Prediabetes in A Biracial Cohort Study. Front Endocrinol (Lausanne). 2018 Mar 13;9:94. doi: 10.3389/fendo.2018.00094. eCollection 2018.
- Results publication: PubMed 28878939Owei I, Umekwe N, Provo C, Wan J, Dagogo-Jack S. Insulin-sensitive and insulin-resistant obese and non-obese phenotypes: role in prediction of incident pre-diabetes in a longitudinal biracial cohort. BMJ Open Diabetes Res Care. 2017 Jul 19;5(1):e000415. doi: 10.1136/bmjdrc-2017-000415. eCollection 2017.
- Derived from this study: PubMed 35273012Dagogo-Jack S, Umekwe N, Brewer AA, Owei I, Mupparaju V, Rosenthal R, Wan J. Outcome of lifestyle intervention in relation to duration of pre-diabetes: the Pathobiology and Reversibility of Prediabetes in a Biracial Cohort (PROP-ABC) study. BMJ Open Diabetes Res Care. 2022 Mar;10(2):e002748. doi: 10.1136/bmjdrc-2021-002748.
- Derived from this study: PubMed 32527719Dagogo-Jack S, Brewer AA, Owei I, French L, Umekwe N, Rosenthal R, Wan J. Pathobiology and Reversibility of Prediabetes in a Biracial Cohort (PROP-ABC) Study: design of lifestyle intervention. BMJ Open Diabetes Res Care. 2020 Jun;8(1):e000899. doi: 10.1136/bmjdrc-2019-000899.
- Individual participant dataSharing planned: No. Group data will be published after completion of study and analysis of results. Individual participant-level information will not 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.
Samuel Dagogo-Jack, MD 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 Intensive Lifestyle Intervention (ILI) in people with Prediabetes and Type 2 Diabetes, 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 1 inclusion and 1 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 15 Oct 2018. 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?
The primary outcome measure is restoration of normal glucose regulation (time frame: Up to 60 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 NCT02027571, which also lists 10 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 15 Oct 2018.