NCT00592670

Brief Summary

It is unclear what effect selective serotonin reuptake inhibitors (SSRIs) have on hypoglycemia. Thus, the American Hospital Formulary Service recommends careful monitoring of blood glucose levels in all patients with diabetes initiating or discontinuing SSRIs (Katz et al., 1996). Because of the increased prevalence of depression in those with diabetes, it is critical to discover what affect the antidepressant therapy may have on counterregulatory responses to hypoglycemia. This study hypothesizes that chronic administration of SSRIs may result in a blunted counterregulatory response to hypoglycemia, thereby leaving individuals more susceptible to hypoglycemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2005

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

March 1, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 1, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 14, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

December 11, 2014

Status Verified

December 1, 2014

Enrollment Period

2.3 years

First QC Date

January 1, 2008

Last Update Submit

December 10, 2014

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Catecholamine measures

    6 weeks

Study Arms (2)

1

EXPERIMENTAL

Baseline measures followed by a randomized 6 weeks treatment of Prozac.

Drug: Fluoxetine

2

PLACEBO COMPARATOR

Baseline followed by a 6 week randomized treatment of placebo.

Drug: Placebo

Interventions

FluoxetineDRUG

20 mg fluoxetine orally one per day for 1 week, 40 mg fluoxetine orally once per day for one week, 80 mg Fluoxetine orally for remaining 4 weeks of treatment

Also known as: Prozac
1
PlaceboDRUG

20 mg placebo pill taken orally once per day for one week, 40 mg placebo pill taken orally one per day for one week, 80 mg placebo pill taken orally once per day for remaining 4 weeks.

2

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • (8 males, 8 females) healthy volunteers aged 18-45 yr
  • (17 males, 17 females) type 1 diabetes volunteers aged 18-45 yr
  • Body mass index 21-30 kg • m-2
  • Normal bedside autonomic function
  • Normal results of routine blood test to screen for hepatic, renal, and hematological abnormalities
  • Female volunteers of childbearing potential: negative HCG pregnancy test
  • Volunteers over 40 years old: normal heart tracing recorded while resting and walking on the treadmill
  • For those with type 1 diabetes: HbA1c \> 7.0%
  • For those with type 1 diabetes: had diabetes for 2-15 years
  • For those with type 1 diabetes: no clinical evidence of diabetic tissue complications

You may not qualify if:

  • Prior history of poor health: any current or prior disease condition that alters carbohydrate metabolism and prior cardiac events and/or evidence for cardiac disease
  • Hemoglobin of less than 12 g/dl
  • Abnormal results following screening tests
  • Pregnancy
  • Subjects with any indication of depression, anxiety, bipolar, panic, or eating disorders
  • Subjects with a past medical history or family history of mania or bipolar disorders
  • Subjects unable to give voluntary informed consent
  • Subjects with a recent medical illness
  • Subjects with known liver or kidney disease
  • Subjects taking steroids
  • Subjects taking beta blockers
  • Subjects on anticoagulant drugs, anemic, or with known bleeding diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232-0475, United States

Location

Related Publications (1)

  • Briscoe VJ, Ertl AC, Tate DB, Davis SN. Effects of the selective serotonin reuptake inhibitor fluoxetine on counterregulatory responses to hypoglycemia in individuals with type 1 diabetes. Diabetes. 2008 Dec;57(12):3315-22. doi: 10.2337/db08-1000. Epub 2008 Oct 3.

    PMID: 18835927DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Stephen N. Davis, MD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman of Medicine.University of Maryland

Study Record Dates

First Submitted

January 1, 2008

First Posted

January 14, 2008

Study Start

March 1, 2005

Primary Completion

June 1, 2007

Study Completion

October 1, 2008

Last Updated

December 11, 2014

Record last verified: 2014-12

Locations

US(1)