Investigation Into the Effects Upon Brain Response to Change in Circulating Glucose Levels in Diabetes Mellitus

NCT00580710 | Completed DMC

• 2 other identifiers: 01080126092R01DK020495-37
• Study Type: observational
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to investigate the effects of diabetes mellitus and its treatment upon the body's responses to low blood glucose (blood sugar) levels. Diabetes is a medical condition in which blood glucose can rise very high. Treatment of diabetes mellitus involves giving insulin (a hormone), which can occasionally cause blood glucose to fall too low. The body responds to low glucose levels by producing a number of hormones, which act against the insulin to help correct the low blood glucose. These hormones also provide symptoms which warn that the glucose is falling too far. These protective warnings by the body may be different in people with diabetes. We want to test whether this also means that diabetes changes the sensitivity of brain function to a lowering of blood glucose levels. In order to answer this question, we need to compare the response of people with diabetes with the response of people who do not have diabetes. The plan of the study is to lower the subject's blood glucose using insulin, while measuring what changes occur in brain function using what is called functional magnetic resonance imaging (fMRI).

Conditions

Type 1 Diabetes; Hypoglycemia

Keywords

type 1 diabetes; hypoglycemia; magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• Brain response to blood glucose levels

  Brain response is operationally defined as: fMRI BOLD signal to detect differences in brain activation in response to changes in glucose levels taken between 4 to 8 weeks after subject enrollment.

  4 to 8 weeks

Study Arms (7)

conventionally treated

conventionally treated, relatively poorly controlled patients with type 1 diabetes

intensively treated

intensively treated, well controlled patients with type 1 diabetes

lean healthy

age- and sex- matched non-diabetic, normal weight (BMI \> or = 18.5 but \< or = 25 kg/m2) control subjects

obese subjects

obese individuals defined as BMI \> or = 30kg/m2

type 2 diabetics

Type 2 diabetics on diet only or diet and Metformin

type 1 diabetes unaware

Type 1 diabetics unaware of hypoglycemic symptoms

type 1 diabetes aware

Type 1 diabetics aware of hypoglycemic symptoms

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The recruited subjects will reflect the gender and ethnic distribution of the Yale and New Haven community. The recruited subjects with type 1 diabetes will reflect the demographics of the clinic population in New Haven. Subject selection is independent of race and sex.

You may qualify if:

• All subjects:
• on a weight maintaining diet
• ability to read and speak English fluently
• Only for Type 1 Diabetics in the intensively treated group: HbA1c \< 7.5% AND documented hypoglycemia at least once per week over at least 4 weeks of frequent daily self monitoring
• Only for Type 1 Diabetics in the conventionally treated group:HbA1c ≥ 8.5%
• Age 18-40 years in the groups 1,2, and 3. Age 18-50 in groups arm 2 obese and control.
• BMI \<30 in the groups 1,2, and 3; BMI \>18.4 but \< or = 25 in the arm control group; and BMI \> or = 30kg/m2 in the obese group.

You may not qualify if:

• Pregnancy
• History of neurologic or cardiovascular disease

Sponsors & Collaborators

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

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

Related Publications (1)

• Parikh L, Seo D, Lacadie C, Belfort-Deaguiar R, Groskreutz D, Hamza M, Dai F, Scheinost D, Sinha R, Todd Constable R, Sherwin R, Hwang JJ. Differential Resting State Connectivity Responses to Glycemic State in Type 1 Diabetes. J Clin Endocrinol Metab. 2020 Jan 1;105(1):1-13. doi: 10.1210/clinem/dgz004.

  PMID: 31511876 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Condition Hierarchy (Ancestors)

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

Study Officials

• Robert Sherwin, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 27, 2007
• Study Start: August 1, 2001
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: April 18, 2022

Record last verified: 2022-04

Locations

US (1)