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Completed

NCT Number: NCT03469492

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

To investigate whether longer-term improvement of glycemic control in poorly controlled diabetes patients with a 12-week intensified insulin treatment regimen will lead to decreased polyol pathway activity.

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Key information

Conditions

Hyperglycaemia (Diabetic) Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

The Anylan Center

New Haven, Connecticut, 06511, United States

About this study

Polyol pathway activity will decrease in diabetic individuals who undergo intensification of their insulin treatment regimens as reflected by lower baseline brain intracellular fructose levels and higher intracellular glutathione levels. Furthermore, following longer-term improved glycemic control, patients may also have down-regulation of the pathway as reflected by decreased production of intracellular fructose in response to hyperglycemic clamp.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 15 Type 2 DM subjects with HbA1C > 7.5%
  • 15 Type 1 DM subjects with HbA1C > 7.5%
  • Age 18-60
  • BMI ≥18 kg/m2
  • Weight ≤ 285 pounds

Exclusion criteria

  • Creatinine > 1.5 mg/dL, Hgb < 10 mg/dL, ALT > 2.5 X ULN,
  • untreated thyroid disease,
  • uncontrolled hypertension,
  • known neurological disorders,
  • untreated psychiatric disorders,
  • malignancy,
  • bleeding disorders,
  • current or recent steroid use in last 3 months,
  • illicit drug use;
  • for women: pregnancy, actively seeking pregnancy, or breastfeeding; inability to enter
  • MRI/MRS

Treatment and study plan

Insulin

Drug

Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level.

Exercise

Behavioral

Exercise in accordance to the guidelines established by the American Diabetes Association.

Dietary counseling

Dietary Supplement

Dietary counseling in accordance to the guidelines established by the American Diabetes Association.

Primary outcomes

  1. Change in HbA1c Levels

    Time frame: 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.

Secondary outcomes

  1. Gluthathione

    Time frame: 0 weeks

    baseline MRS scan to measure gluthathione

  2. Gluthathione

    Time frame: 12 weeks

    MRS scan to measure gluthathione

  3. Plasma Glucose

    Time frame: 0 weeks

    MRS scan to measure plasma glucose

  4. Plasma Glucose

    Time frame: 12 weeks

    MRS scan to measure plasma glucose

  5. Plasma Fructose

    Time frame: 0 weeks

    MRS scan to measure plasma fructose

  6. Plasma Fructose

    Time frame: 12 weeks

    MRS scan to measure plasma fructose

  7. Plasma Insulin

    Time frame: 0 weeks

    MRS scan to measure plasma insulin

  8. Plasma Insulin

    Time frame: 12 weeks

    MRS scan to measure plasma insulin

Other outcomes

  1. Optional Hyperglycemic Clamp

    Time frame: upon enrollment

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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Investigating the Role of the Polyol Pathway in the Central Nervous System Production of Fructose: an Intervention Study

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 19, 2018
Registry last updated
Feb 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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