Trial Outcomes & Findings for Omega-3 Fatty Acids and Insulin Sensitivity (NCT NCT01686568)

Results Overview

A 2-stage insulin clamp will be performed with titration of dextrose to maintain euglycemia. D2 glucose will be infused to evaluate hepatic glucose production at baseline and in response to insulin. Hyperinsulinemic-euglycemic clamp technique: The plasma insulin concentration is acutely raised and maintained by a continuous infusion of insulin. Meanwhile, the plasma glucose concentration is held constant at basal levels by a variable glucose infusion. When the steady-state is achieved, the glucose infusion rate (GIR) equals glucose uptake by all the tissues in the body and is therefore a measure of tissue insulin sensitivity.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

31 participants

Primary outcome timeframe

Baseline, after 6 months of treatment

Results posted on

2017-03-03

Participant Flow

Participants were recruited from the Mayo Clinic in Rochester, Minnesota.

Participant milestones

Participant milestones
Measure	Omega-3 Patients in this group will receive oral supplementation with EPA + Docosahexaenoic acid (DHA) (3.9grams/day) for 6 months.	Placebo Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
Main Study STARTED	16	15
Main Study COMPLETED	14	11
Main Study NOT COMPLETED	2	4
Sub-Study STARTED	14	11
Sub-Study COMPLETED	12	9
Sub-Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Omega-3 Patients in this group will receive oral supplementation with EPA + Docosahexaenoic acid (DHA) (3.9grams/day) for 6 months.	Placebo Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
Main Study Withdrawal by Subject	1	3
Main Study Noncompliance with protocol	0	1
Main Study Liver enzymes above range of exclusion	1	0
Sub-Study Not consented for sub-study	2	2

Baseline Characteristics

Omega-3 Fatty Acids and Insulin Sensitivity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Omega-3 n=14 Participants Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.	Placebo n=11 Participants Patients in this group will be supplemented with placebo capsules containing ethyl oleate.	Total n=25 Participants Total of all reporting groups
Age, Continuous	35.3 years STANDARD_DEVIATION 2.9 • n=93 Participants	32.6 years STANDARD_DEVIATION 2.5 • n=4 Participants	34.1 years STANDARD_DEVIATION 9.7 • n=27 Participants
Sex: Female, Male Female	9 Participants n=93 Participants	9 Participants n=4 Participants	18 Participants n=27 Participants
Sex: Female, Male Male	5 Participants n=93 Participants	2 Participants n=4 Participants	7 Participants n=27 Participants
Region of Enrollment United States	14 participants n=93 Participants	11 participants n=4 Participants	25 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline, after 6 months of treatment

A 2-stage insulin clamp will be performed with titration of dextrose to maintain euglycemia. D2 glucose will be infused to evaluate hepatic glucose production at baseline and in response to insulin. Hyperinsulinemic-euglycemic clamp technique: The plasma insulin concentration is acutely raised and maintained by a continuous infusion of insulin. Meanwhile, the plasma glucose concentration is held constant at basal levels by a variable glucose infusion. When the steady-state is achieved, the glucose infusion rate (GIR) equals glucose uptake by all the tissues in the body and is therefore a measure of tissue insulin sensitivity.

Outcome measures

Outcome measures
Measure	Omega-3 n=14 Participants Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.	Placebo n=11 Participants Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
Insulin Sensitivity by Hyperinsulinemic-euglycemic Clamp at Baseline and 6 Month Follow up Baseline	10.92 mg/kg FFM/min Standard Error 1.04	10.39 mg/kg FFM/min Standard Error 0.76
Insulin Sensitivity by Hyperinsulinemic-euglycemic Clamp at Baseline and 6 Month Follow up 6 Month Follow Up	10.16 mg/kg FFM/min Standard Error 1.02	10.80 mg/kg FFM/min Standard Error 0.73

SECONDARY outcome

Timeframe: baseline, after 6 months of treatment

Following consumption of a mixed meal, beta cell function will be evaluated from serial measurements of C-peptide. C-peptide was measured using a two-side immunometric assay using electrochemiluminescence detection.

Outcome measures

Outcome measures
Measure	Omega-3 n=14 Participants Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.	Placebo n=11 Participants Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
Beta Cell Function From Insulin Secretion Following Ingestion of a Mixed Meal at Baseline and 6 Month Follow up Baseline	537.17 nmol/L Standard Error 45.33	488.90 nmol/L Standard Error 45.47
Beta Cell Function From Insulin Secretion Following Ingestion of a Mixed Meal at Baseline and 6 Month Follow up 6 Month Follow Up	561.33 nmol/L Standard Error 48.21	504.39 nmol/L Standard Error 35.93

SECONDARY outcome

Timeframe: Baseline, after 6 months of treatment

Measurements of oxygen consumption in isolated mitochondria will be performed using a polarographic oxygen electrode.