Trial Outcomes & Findings for Investigating the Role of the Polyol Pathway in the Central Nervous System Production of Fructose (NCT NCT03469492)

Last Updated: 2024-02-05

Results Overview

HbA1c levels measured by MRS scanning during a hyperglycaemic clamp. Result reported is the mean decrease in HbA1C. A decrease in HbA1c indicates improvement in brain glucose levels.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

8 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2024-02-05

Participant Flow

Participant milestones

Participant milestones
Measure	Type 2 Diabetes Mellitus Subjects with type 2 diabetes on insulin. Insulin: Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level. exercise: Exercise in accordance to the guidelines established by the American Diabetes Association. Dietary counseling: Dietary counseling in accordance to the guidelines established by the American Diabetes Association.
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Investigating the Role of the Polyol Pathway in the Central Nervous System Production of Fructose

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Type 2 Diabetes Mellitus n=8 Participants Subjects with type 2 diabetes on insulin. Insulin: Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level. exercise: Exercise in accordance to the guidelines established by the American Diabetes Association. Dietary counseling: Dietary counseling in accordance to the guidelines established by the American Diabetes Association.
Age, Continuous	44.8 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Region of Enrollment United States	8 Participants n=5 Participants
Duration of Diabetes	10 years STANDARD_DEVIATION 8.2 • n=5 Participants
BMI	31.4 kilograms/meter square STANDARD_DEVIATION 6.1 • n=5 Participants
Weight	85 kilograms STANDARD_DEVIATION 21.2 • n=5 Participants
HbA1c	9.8 percentage glycated hemoglobin STANDARD_DEVIATION 1.4 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

HbA1c levels measured by MRS scanning during a hyperglycaemic clamp. Result reported is the mean decrease in HbA1C. A decrease in HbA1c indicates improvement in brain glucose levels.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Mellitus n=8 Participants Subjects with type 2 diabetes on insulin. Insulin: Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level. exercise: Exercise in accordance to the guidelines established by the American Diabetes Association. Dietary counseling: Dietary counseling in accordance to the guidelines established by the American Diabetes Association.
Change in HbA1c Levels	24.3 mmol/mol Standard Deviation 15.3

SECONDARY outcome

Timeframe: 0 weeks

Population: Data for this outcome not collected.

baseline MRS scan to measure gluthathione

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Data for this outcome not collected.

MRS scan to measure gluthathione

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0 weeks

MRS scan to measure plasma glucose

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Mellitus n=8 Participants Subjects with type 2 diabetes on insulin. Insulin: Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level. exercise: Exercise in accordance to the guidelines established by the American Diabetes Association. Dietary counseling: Dietary counseling in accordance to the guidelines established by the American Diabetes Association.
Plasma Glucose	1.07 mmol/l Standard Deviation .23

SECONDARY outcome

Timeframe: 12 weeks

MRS scan to measure plasma glucose

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Mellitus n=8 Participants Subjects with type 2 diabetes on insulin. Insulin: Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level. exercise: Exercise in accordance to the guidelines established by the American Diabetes Association. Dietary counseling: Dietary counseling in accordance to the guidelines established by the American Diabetes Association.
Plasma Glucose	0.88 mmol/l Standard Deviation 0.35

SECONDARY outcome

Timeframe: 0 weeks

Population: Data for this outcome not collected.

MRS scan to measure plasma fructose

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Data for this outcome not collected.

MRS scan to measure plasma fructose

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0 weeks

MRS scan to measure plasma insulin

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Mellitus n=8 Participants Subjects with type 2 diabetes on insulin. Insulin: Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level. exercise: Exercise in accordance to the guidelines established by the American Diabetes Association. Dietary counseling: Dietary counseling in accordance to the guidelines established by the American Diabetes Association.
Plasma Insulin	31 μU/ml Standard Deviation 26

SECONDARY outcome

Timeframe: 12 weeks

MRS scan to measure plasma insulin

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Mellitus n=8 Participants Subjects with type 2 diabetes on insulin. Insulin: Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level. exercise: Exercise in accordance to the guidelines established by the American Diabetes Association. Dietary counseling: Dietary counseling in accordance to the guidelines established by the American Diabetes Association.
Plasma Insulin	38 μU/ml Standard Deviation 29

OTHER_PRE_SPECIFIED outcome

Timeframe: upon enrollment

Hyperglycemic clamp administered to measure glucose levels. Data represented is the number of participants the clamp was used on successfully.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Mellitus n=8 Participants Subjects with type 2 diabetes on insulin. Insulin: Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level. exercise: Exercise in accordance to the guidelines established by the American Diabetes Association. Dietary counseling: Dietary counseling in accordance to the guidelines established by the American Diabetes Association.
Optional Hyperglycemic Clamp	8 participants

Adverse Events

Type 2 Diabetes Mellitus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elizabeth Sanchez Rangel, MD

Yale School Of Medicine

Phone: 203-737-6067

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place