Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus

NCT00607646 | Completed Early Phase 1 DMC

• 2 other identifiers: HP-00044672-DHEAR01DK069803-03
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Elevations of plasma cortisol, a stress hormone, during prior episodes of low blood sugar (hypoglycemia) appear to be responsible for the deficient responses during subsequent hypoglycemia. Our specific aim is to determine if dehydroepiandrosterone (DHEA), a hormone with anti-corticosteroid actions, can prevent hypoglycemia associated autonomic failure in type 1 diabetic volunteers.

Conditions

Type 1 Diabetes

Keywords

hypoglycemia; dehydroepiandrosterone

Outcome Measures

Primary Outcomes (1)

• Change in level of catecholamines in blood from baseline

  6 weeks

Study Arms (4)

1

EXPERIMENTAL

Hyperinsulinemic (high dose insulin) hypoglycemic clamp studies with oral administration of DHEA or placebo prior to each clamp x 2 on day 1. Day 2 hyperinsulinemic hypoglycemia. Participant randomized to either DHEA or placebo for baseline trial (arm 1) and 6 weeks treatment.

Drug: Dehydroepiandrosterone

2

EXPERIMENTAL

Following 6 weeks randomized treatment, Day 1 hyperinsulinemic hypoglycemic clamps x 2 with DHEA or placebo dose given prior to each clamp. Day 2 hypoglycemia with prior dose of randomized treatment.

Drug: Dehydroepiandrosterone

Arm 3 (optional)

EXPERIMENTAL

Individuals will be asked to return after at least 2 months and repeat the trial they did not complete (for example, placebo if they were in the DHEA trial before). Again Day 1 would consist of two hyperinsulinemic clamps with placebo or DHEA given orally. Day 2 hyperinsulinemic hypoglycemic clamp with oral administration of placebo or DHEA.

Drug: Placebo

Arm 4

EXPERIMENTAL

Following 6 weeks randomized treatment, Day 1 hyperinsulinemic hypoglycemic clamps x 2 with DHEA or placebo dose given prior to each clamp. Day 2 hypoglycemia with prior dose of randomized treatment.

Drug: Placebo

Interventions

Dehydroepiandrosterone DRUG

Placebo tablets or tablets containing DHEA will be given orally before each hyperinsulinemic clamps on day 1 (x 2). Placebo tablets or tablets containing DHEA will be given orally before Day 2 hyperinsulinemic hypoglycemic clamp x 1.

Also known as: DHEA

1; 2

Placebo DRUG

Placebo oral administration prior to each clamp period x2 on day 1. Hyperinsulinemic hypoglycemia on day 2.

Arm 3 (optional); Arm 4

Eligibility Criteria

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

You may qualify if:

• (14 males, 14 females) Healthy volunteers aged 18-45 yr.
• (14 males, 14 females) Type 1 diabetic patients aged 18-45 yr.
• HbA1c \< 11.0%
• Has been diagnosed Type 1 DM
• No major diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc)
• Body mass index \< 40kg/m-2

You may not qualify if:

• \- pregnancy
• Medical history-
• Hepatic Failure/Jaundice
• Renal Failure
• Acute Cerebrovascular/ Neurological deficit
• Physical Exam-
• Pneumonia
• Fever greater than 38.0 C
• Blood labs according to protocol

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Stephen N. Davis, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 16, 2008
• First Posted: February 6, 2008
• Study Start: October 1, 2010
• Primary Completion: October 9, 2018
• Study Completion: October 9, 2018
• Last Updated: September 12, 2019

Record last verified: 2019-09

Locations

US (1)