RECRUITING

Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)

Conditions

Diabetes Mellitus, Type 2 Impaired Glucose Tolerance (IGT)Impaired Fasting Glucose (IFG)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

HYPOTHESIS: Impaired glucose tolerance (IGT) and impaired fasting glucose (IFG) have distinct pathophysiologic etiologies. Therefore, therapeutic interventions designed to correct the specific underlying pathogenic abnormalities in IGT and IFG will be required to optimally prevent the progressive beta cell failure and development of overt type 2 diabetes.

Official Title

Preservation of Beta Cell Function in Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)

Quick Facts

Study Start:2014-01-01

Study Completion:2027-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02969798

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* NGT subjects will serve as controls and will be matched in age, gender, ethnicity, and BMI to IGT and IFG subjects 1. Male or female subjects between the ages of 18 and 65 years of age, inclusive, at Screening. 2. FPG \< 100 mg/dl and 2-h PG \< 140 mg/dl 3. BMI = 24-40 kg/m2; 4. Stable body weight (±4lbs) over the preceding 3 months 5. Subjects with no evidence of major organ system disease as determined by physical exam, history, and screening laboratory data 6. Females of childbearing potential with a negative pregnancy test at Screening and Treatment visits, using one of the following forms of contraception for the duration of participation in the study (i.e., until Follow-up 7-14 days post last dose): * Oral contraceptive * Injectable progesterone * Subdermal implant * Spermicidal foam/gel/film/cream/suppository * Diaphragm with spermicide * Copper or hormonal containing IUD * Sterile male partner vasectomized \> 6 month pre-dosing. 7. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. 8. Subjects must be willing and able to comply with scheduled visits, treatment, laboratory tests and study procedures.	1. Recent (i.e., within three (3) months prior to Screening) evidence or medical history of unstable concurrent disease such as: documented evidence or history of clinically significant hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, immunological, or clinically significant neurological disease. 2. Subjects with a family history of diabetes in a first degree relative 3. BMI of less than 24 or greater than 40 kg/m2 4. Unstable body weight (change of greater than ±4lbs over the preceding 3 months 5. Subjects participating in an excessively heavy exercise program 6. Subject with a feeding/sleeping schedule different from a daytime feeding/night time sleeping schedule 7. Subjects taking medications known to alter glucose metabolism (with the exception of metformin and/or pioglitazone) or which effect brain neurosynaptic function are excluded. 8. Subjects with evidence of major organ system disease as determined by physical exam, history, and screening laboratory data 9. Pregnant subjects or subjects unwilling to use birth control during their study enrollment 10. Blood donation of approximately 1 pint (500 mL) within 8 weeks prior to Screening. 11. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study 12. Subjects with hematuria will be excluded. 13. Subjects with evidence or prior history of heart failure will be excluded 14. Subjects with family history of pancreatic, bladder, and breast cancer will be excluded. 15. Subjects with history of pancreatitis will be excluded. 16. Subjects with eGFR \< 60 ±5 ml/min.1.73m2 will be excluded. 17. Subjects with elevated serum creatinine (\>1.5 mg/dl males/1.4 mg/dl females) will be excluded. 18. Subjects with a history of orthostatic hypotension (\>15/10 mmHg) will be excluded. 19. Subjects with liver enzymes (ALT, AST) \>3-fold above upper normal limit will be excluded. 20. Subjects with a history of hypersensitivity to pioglitazone, dapagliflozin, or Saxagliptin will be excluded.

Inclusion Criteria

Exclusion Criteria

* NGT subjects will serve as controls and will be matched in age, gender, ethnicity, and BMI to IGT and IFG subjects
1. Male or female subjects between the ages of 18 and 65 years of age, inclusive, at Screening.
2. FPG \< 100 mg/dl and 2-h PG \< 140 mg/dl
3. BMI = 24-40 kg/m2;
4. Stable body weight (±4lbs) over the preceding 3 months
5. Subjects with no evidence of major organ system disease as determined by physical exam, history, and screening laboratory data
6. Females of childbearing potential with a negative pregnancy test at Screening and Treatment visits, using one of the following forms of contraception for the duration of participation in the study (i.e., until Follow-up 7-14 days post last dose):
* Oral contraceptive
* Injectable progesterone
* Subdermal implant
* Spermicidal foam/gel/film/cream/suppository
* Diaphragm with spermicide
* Copper or hormonal containing IUD
* Sterile male partner vasectomized \> 6 month pre-dosing.
7. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
8. Subjects must be willing and able to comply with scheduled visits, treatment, laboratory tests and study procedures.

1. Recent (i.e., within three (3) months prior to Screening) evidence or medical history of unstable concurrent disease such as: documented evidence or history of clinically significant hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, immunological, or clinically significant neurological disease.
2. Subjects with a family history of diabetes in a first degree relative
3. BMI of less than 24 or greater than 40 kg/m2
4. Unstable body weight (change of greater than ±4lbs over the preceding 3 months
5. Subjects participating in an excessively heavy exercise program
6. Subject with a feeding/sleeping schedule different from a daytime feeding/night time sleeping schedule
7. Subjects taking medications known to alter glucose metabolism (with the exception of metformin and/or pioglitazone) or which effect brain neurosynaptic function are excluded.
8. Subjects with evidence of major organ system disease as determined by physical exam, history, and screening laboratory data
9. Pregnant subjects or subjects unwilling to use birth control during their study enrollment
10. Blood donation of approximately 1 pint (500 mL) within 8 weeks prior to Screening.
11. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
12. Subjects with hematuria will be excluded.
13. Subjects with evidence or prior history of heart failure will be excluded
14. Subjects with family history of pancreatic, bladder, and breast cancer will be excluded.
15. Subjects with history of pancreatitis will be excluded.
16. Subjects with eGFR \< 60 ±5 ml/min.1.73m2 will be excluded.
17. Subjects with elevated serum creatinine (\>1.5 mg/dl males/1.4 mg/dl females) will be excluded.
18. Subjects with a history of orthostatic hypotension (\>15/10 mmHg) will be excluded.
19. Subjects with liver enzymes (ALT, AST) \>3-fold above upper normal limit will be excluded.
20. Subjects with a history of hypersensitivity to pioglitazone, dapagliflozin, or Saxagliptin will be excluded.

Contacts and Locations

Study Contact

Ralph A DeFronzo, MD

CONTACT

210-567-6691

defronzo@uthscsa.edu

Monica Palomo, BS

CONTACT

210-567-6710

palomom@uthscsa.edu

Principal Investigator

Ralph A DeFronzo, MD

PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Study Locations (Sites)

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center at San Antonio

Ralph A DeFronzo, MD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center at San Antonio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2014-01-01

Study Completion Date2027-07

Study Record Updates

Study Start Date2014-01-01

Study Completion Date2027-07

Terms related to this study

Additional Relevant MeSH Terms

Diabetes Mellitus, Type 2
Impaired Glucose Tolerance (IGT)
Impaired Fasting Glucose (IFG)