Central Mechanisms That Regulate Glucose Metabolism in Humans

NCT01028846 | Terminated Phase 4 Results FDA Drug

• 2 other identifiers: 2006-414R01DK069861
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Type 2 diabetes is a chronic condition that affects the ability of the body to regulate glucose (sugar). When glucose levels are low, the liver can make glucose to increase levels in the body. This important process is called endogenous glucose production (EGP). Previous studies suggest that the central nervous system (CNS), including the brain, helps to coordinate this process by communicating with the liver through potassium channels. Control of EGP can be impaired in people with type 2 diabetes, which may contribute to the high levels of glucose seen in these individuals. The purpose of this study is to understand how activating these potassium channels in the control centers of the brain with a medication called diazoxide might inhibit the amount of glucose made by the liver. This is particularly important for people with diabetes who have very high production of glucose, which in turn causes hyperglycemia (high levels of sugar in the blood) that leads to diabetes complications.

Conditions

Type 2 Diabetes; Glucose Metabolism Disorders; Glucose, High Blood

Keywords

Type 2 Diabetes; Diabetes

Outcome Measures

Primary Outcomes (1)

• Rate of Endogenous Glucose Production (EGP)

  Rate of EGP (a measure of the body's production of sugar) was measured using analysis of blood samples taken throughout the pancreatic clamp procedure under various treatment conditions (e.g., diazoxide or placebo) by monitoring changes in the level of a non-radioactive, naturally occurring form of glucose (sugar). Rates were summarized by treatment (Diazoxide or Placebo) in mg/kg/min sing basic descriptive statistics.

  Final 60 minutes (t=180-240 minutes) of the pancreatic clamp, 6-7 hours after dosing

Study Arms (2)

Diazoxide

ACTIVE COMPARATOR

4 mg/kg body weight total dosage administered orally during pancreatic clamp study

Drug: Diazoxide

Placebo

PLACEBO COMPARATOR

Saline administered orally during pancreatic clamp study

Drug: Placebo

Interventions

Diazoxide DRUG

4 mg/kg body weight total dosage administered orally

Also known as: Proglycem

Diazoxide

Placebo DRUG

Oral saline

Placebo

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers
• Be no more than 140% of body weight
• No concurrent illnesses

You may not qualify if:

• No clinical history or laboratory evidence of hyperlipidemia (LDL cholesterol \< 160 mg/dL)
• Clinical history of Hypertension
• Clinical history of Heart disease
• Clinical history of Cerebrovascular disease
• Clinical history of Seizures
• Clinical history of Bleeding disorders
• Clinical history of Muscle disease
• Smokers
• Mentally disabled persons
• Prisoners
• Pregnancy
• Clinical history of ethanol or drug or toxin exposure which could be associated with neuropathy
• Subjects incapable of giving voluntary informed consent
• History of bleeding disorder
• Clinical history of prolonged Prothrombin Time (PT) or Partial Thromboplastin Time

Sponsors & Collaborators

• Meredith Hawkins: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• American Diabetes Association: collaborator

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Related Publications (1)

• Kishore P, Boucai L, Zhang K, Li W, Koppaka S, Kehlenbrink S, Schiwek A, Esterson YB, Mehta D, Bursheh S, Su Y, Gutierrez-Juarez R, Muzumdar R, Schwartz GJ, Hawkins M. Activation of K(ATP) channels suppresses glucose production in humans. J Clin Invest. 2011 Dec;121(12):4916-20. doi: 10.1172/JCI58035. Epub 2011 Nov 7.

  PMID: 22056385 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Diabetes Mellitus

Interventions

Diazoxide

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Meredith Hawkins
• Organization: Albert Einstein College of Medicine

meredith.hawkins@einsteinmed.edu

718-839-7975

Study Officials

• Meredith Hawkins, M.D., M.S.

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: All participants received placebo or diazoxide in a randomized, double-blinded fashion.

Study Record Dates

• First Submitted: December 7, 2009
• First Posted: December 9, 2009
• Study Start: November 2, 2006
• Primary Completion: December 5, 2007
• Study Completion: December 5, 2007
• Last Updated: May 16, 2025
• Results First Posted: March 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)