NCT03469492

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jan 2018

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

January 18, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2020

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

February 2, 2023

Completed
Last Updated

February 5, 2024

Status Verified

February 1, 2024

Enrollment Period

2.2 years

First QC Date

January 11, 2018

Results QC Date

November 18, 2022

Last Update Submit

February 1, 2024

Conditions

Hyperglycaemia (Diabetic)

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c Levels

    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.

    Baseline and 12 weeks

Secondary Outcomes (8)

  • Gluthathione

    0 weeks

  • Gluthathione

    12 weeks

  • Plasma Glucose

    0 weeks

  • Plasma Glucose

    12 weeks

  • Plasma Fructose

    0 weeks

  • +3 more secondary outcomes

Other Outcomes (1)

  • Optional Hyperglycemic Clamp

    upon enrollment

Study Arms (2)

type 2 diabetes mellitus

ACTIVE COMPARATOR

Subjects with type 2 diabetes on insulin.

Drug: InsulinBehavioral: exerciseDietary Supplement: Dietary counseling

type 1 diabetes mellitus

ACTIVE COMPARATOR

Subjects with type 1 diabetes on insulin.

Drug: InsulinBehavioral: exerciseDietary Supplement: Dietary counseling

Interventions

InsulinDRUG

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

type 1 diabetes mellitustype 2 diabetes mellitus
exerciseBEHAVIORAL

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

type 1 diabetes mellitustype 2 diabetes mellitus
Dietary counselingDIETARY_SUPPLEMENT

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

type 1 diabetes mellitustype 2 diabetes mellitus

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Anylan Center

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

  • Sanchez-Rangel E, Gunawan F, Jiang L, Savoye M, Dai F, Coppoli A, Rothman DL, Mason GF, Hwang JJ. Reversibility of brain glucose kinetics in type 2 diabetes mellitus. Diabetologia. 2022 May;65(5):895-905. doi: 10.1007/s00125-022-05664-y. Epub 2022 Mar 5.

    PMID: 35247067DERIVED

MeSH Terms

Conditions

Hyperglycemia

Interventions

InsulinExerciseNutrition Assessment

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Results Point of Contact

Title
Elizabeth Sanchez Rangel, MD
Organization
Yale School Of Medicine
elizabeth.sanchezrangel@yale.edu
203-737-6067

Study Officials

  • Janice Hwang, MD

    Section of Endocrinology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2018

First Posted

March 19, 2018

Study Start

January 18, 2018

Primary Completion

March 20, 2020

Study Completion

March 20, 2020

Last Updated

February 5, 2024

Results First Posted

February 2, 2023

Record last verified: 2024-02

Locations

US(1)