Isolated Impaired Fasting Glucose Clinical Trial
Official title:
Effect of High-Intensity Interval Training on Fasting Hyperglycemia in People With Isolated Impaired Fasting Glucose: A Proof-of-Concept Study
This is a pilot randomized controlled trial of 20 physically inactive i-IFG adults aged 35-55 years with overweight or obesity. The investigators will test the effects of HIIT on fasting hyperglycemia, the pathophysiology of i-IFG, and continuous glucose monitoring (CGM) metrics compared with the control participants who will receive standard lifestyle recommendations. The research team will also examine the feasibility of conducting the study procedures and assess the acceptability of HIIT intervention.
This study is a 1:1 proof-of-concept randomized controlled trial (RCT) involving 34 physically inactive individuals aged 35-65 years who are overweight or obese and have isolated impaired fasting glucose (i-IFG). Participants will be identified through various sources and will undergo eligibility screening via phone calls. Those potentially eligible will be invited to the Georgia Clinical and Translational Science Alliance at Emory University Hospital in Atlanta for further assessment. During their visit, participants will complete questionnaires, undergo an oral glucose tolerance test, and provide blood samples for insulin and alanine aminotransferase analysis. Those assigned to the intervention group will participate in supervised high-intensity interval training (HIIT) sessions using stationary 'Spin' cycle ergometers in groups of five or fewer. They will wear continuous glucose monitoring (CGM) devices for 10 days before the intervention, throughout the 8-week intervention period, and for 10 days post-intervention. The intervention will be conducted three times a week for eight weeks at the Aerobic Exercise Laboratory in the Rehabilitation Hospital at Emory University. Control participants will be instructed to refrain from engaging in intense physical activities during the study period and will also wear CGM devices for the same duration as the intervention participants. All participants will be asked to maintain their routine dietary habits throughout the study. Assessments at baseline and after eight weeks will include measurements of weight, blood pressure, body composition, waist and hip circumferences, as well as levels of glucose, insulin, and alanine aminotransferase. Additionally, intervention participants will complete an intervention acceptability questionnaire upon completing the intervention. The study outcomes will include between-group changes in CGM metrics and clinical measures, feasibility parameters, and intervention acceptability. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06451055 -
Low-calorie Diet in Isolated Impaired Fasting Glucose
|
N/A | |
| Completed |
NCT00140647 -
The Study of Atherosclerosis With Ramipril and Rosiglitazone
|
Phase 3 |