Metabolic Causes of Thrombosis in Type 2 Diabetes

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2011-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Hypoglycemia (low blood glucose level) occurs frequently in intensively treated patients with diabetes. Although hypoglycemia was thought to occur almost exclusively in T1DM, with the advent of improved metabolic control in T2DM, the incidence of hypoglycemia is rising in these patients. Therefore in this application, we will test the novel hypothesis that prior hypoglycemia will result in (cardiovascular complications) during subsequent hypoglycemia.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

GLP-1 and Hypoglycemia

NCT01858896

Type 2 Diabetes Mellitus

ACTIVE_NOT_RECRUITING EARLY_PHASE1

Effect of Glucagon on Fasting Insulin Secretion and Glucose Metabolism in Subjects Without Type 2 Diabetes

NCT06424106

PreDiabetes

RECRUITING NA

Effects of Modulators of Gluconeogenesis, Glycogenolysis and Glucokinase Activity

NCT05098470

Type 2 Diabetes

ACTIVE_NOT_RECRUITING PHASE3

The Effects of Hypoglycaemia in People With Type 2 Diabetes

NCT02205996

Type 2 Diabetes Mellitus

COMPLETED NA

HbA1c Variability in Type II Diabetes

NCT02879409

Diabetes Mellitus Type 2

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study will test the hypothesis that 1) hypoglycemia causes a prothrombotic state and defective endothelial function and 2) episodes of repeated hypoglycemia will result in greater impairments of endothelial function and an increased prothrombotic tendency. Preliminary data in healthy men demonstrates that hypoglycemia can dramatically increase PAI-1 levels and the PAI-1 to tPA ratio, thereby creating a prothrombotic state. Whether this also occurs in type 2 DM patients is unknown. Furthermore, the effects of hypoglycemia on endothelial function in T2DM are also unknown.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control study then antecedent hypoglycemia study group

Day 1 euglycemia, day 2 hypoglycemia Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks then participants proceeded to antecedent hypoglycemia study Day 1 hypoglycemia, Day 2 hypoglycemia

Group Type ACTIVE_COMPARATOR

Hyperinsulinemic Hypoglycemic Clamp

Intervention Type OTHER

all participants received (2) hyperinsulinemic glucose clamp studies separated by 8 weeks

Antecedent Hypoglycemic clamp study

Day 1 hypoglycemia, day 2 hypoglycemia Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks then participants proceeded to control study Day 1 euglycemia, Day 2 hypoglycemia

Group Type ACTIVE_COMPARATOR

Hyperinsulinemic Hypoglycemic Clamp

Intervention Type OTHER

all participants received (2) hyperinsulinemic glucose clamp studies separated by 8 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hyperinsulinemic Hypoglycemic Clamp

all participants received (2) hyperinsulinemic glucose clamp studies separated by 8 weeks

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 14 (7 female/ 7 male) Type 2 diabetic patients age 18-60 yrs
* 14 (7 female/ 7 male) Non-diabetic controls age and weight matched
* Body mass index \>20 kg/m2
* 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 baseline cardiac stress test
* For those with type 2 diabetes: HBA1C \>5.5%
* For those with type 2 diabetes: diabetes \< 20 years
* For those with type 2 diabetes: C-peptide \>0.2 nmol (1.1-4.4 ng/ml). If c-peptide is abnormal or there is a clinical suspicion of type 1 diabetes, MODY, or LADA, Anti-Islet cell (negative) and Glutamic Acid Decarboxylase (GAD) antibody negative (0.0-1.5 U/ml) will be performed

Exclusion Criteria

* Uncontrolled hypertension
* History of cerebrovascular incidents
* Pregnancy
* Subjects unable to give voluntary informed consent
* Subjects with a recent medical illness
* Subjects on anticoagulant drugs, anemic, or with known bleeding diseases
* Tobacco Use

* Blood Pressure greater than 150/95
* Clinically significant Cardiac Abnormalities (e.g. Heart Failure, Arrhythmias, ischemic tachycardia, S-T segment deviations, ect.) from history or from cardiac stress testing
* Pneumonia
* Hepatic Failure/Jaundice
* Renal Failure
* Acute Cerebrovascular/ Neurological deficit
* Fever greater than 38.0 C

Screening blood tests exclusions according to protocol

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes